Recall Archives 22

... Up One Level
CURRENT RECALLS
Recall Archives 1
Recall Archives 2
Recall Archives 3
Recall Archives 4
Recall Archives 5
Recall Archives 6
Recall Archives 7
Recall Archives 8
Recall Archives 9
Recall Archives 10
Recall Archives 11
Recall Archives 12
Recall Archives 13
Recall Archives 14
Recall Archives 15
Recall Archives 16
Recall Archives 17
Recall Archives 18
Recall Archives 19
Recall Archives 20
Recall Archives 21
Recall Archives 22
Recall Archives 23
Recall Archives 24
Recall Archives 25
Recall Archives 26
Recall Archives 27
Recall Archives 28

Recall Archives 22

FDA Recalls

July 1, 2007 - December 30, 2007

Recalls as of June 25, 2008
recalls as of June 18, 2008
Recalls as of June 11, 2008
Recalls as of June 4, 2008
Recalls as of May 28, 2008
Recalls as of May 21, 2008
Recalls as of May 14, 2008
Recalls as of May 7, 2008
Recalls as of April 30, 2008
Recalls as of April 23, 2008
Recalls as of April 16, 2008
Recalls as of April 9, 2008
Recalls as of April 2, 2008
Recalls as of March 26, 2008
Recalls as of March 19, 2008
Recalls as of March 12, 2008
Recalls as of March 5, 2008
Recalls as of February 27, 2008
Recalls as of February 20, 2008
Recalls as of February 13, 2008
Recalls as of February 6, 2008
Recalls as of January 30, 2008
Recalls as of January 23, 2008
Recalls as of January 16, 2008
Recalls as of January 9, 2008
Recalls as of January 2, 2008

THERE IS NO RECALL FOR JUNE 25, 2008

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 18, 2008:

CLASS II

PRODUCT: GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2, Recall # Z-1155-2008

MANUFACTURER: Recalling Firm: GE Healthcare Clinical Systems, Milwaukee, WI, by letter dated August 14, 2007. Manufacturer: Wipro GE Medical Systems Ltd., Whitefield, Bangalore, India. Firm initiated recall is ongoing.

REASON: Inaccurate guidelines: The BE9C is an optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3 Expert system in Urology application. An attempt by the user to activate the biopsy guidelines while this probe is in use will cause incorrect guidelines to be displayed on the image. The incorrect guidelines are recognized by their orientation that is left/right reversed from the usual guideline orientation. Any attempt to use the inaccurate guidelines may result in a biopsy needle puncture at the unintended location.

PRODUCT:
a) BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450. The product is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidium IgG antibodies in human serum, Recall # Z-1156-2008;
b) BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies to three (3) seperate EBV antigens in human serum. They are: 1) Epstein-Barr Virus Nuclear Antigen-1 (EBV-NA-1); 2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D), Recall # Z-1157-2008;
c) BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests – Catalog No. 665-1350. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum, Recall # Z-1158-2008;
d) BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test – Catalog No. 665-1150; and b) the 5,000 tests - Catalog No. 665-1155. The product is used as an aid in the diagnosis of systemic autoimmune diseases, Recall # Z-1159-2008

MANUFACTURER: Bio-Rad Laboratories, Redmond, WA, by letters dated November 9, 2007 and telephone. Firm initiated recall is ongoing.

REASON: False negative results due to reagent packs exhibiting low signal.

PRODUCT: da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Recall # Z-1180-2008

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by visit and letter beginning December 28, 2007. Firm initiated recall is complete.

REASON: Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.

PRODUCT:
a) Trident Hemispherical Solid BK Acetabular Shells; 42mm to 74mm, Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis Component. Catalog number: 500-01-42A, 42 mm; 500-01-44B, 44 mm; 500-01-56C, 46mm; 500-01-48D, 48mm; 500-01-50D, 50mm; 500-01-52E, 52mm; 500-01-54D, 54mm; 500-01-56, 56mm; 500-01-58E, 58E; 500-01-60G, 60mm; 500-01-62G, 62mm; 500-01-64H, 64mm; 500-01-66H, 66mm; 500-01-68I, 68mm; 500-01-701, 70mm; 500-01-72J, 72mm; 500-01-74J, 74mm, Recall # Z-1168-2008;
b) Trident Hemispherical Acetabular Shells HA Solid BK 42mm- 74mm; Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics; Catalog Number’s: 500-11-42A, 42mm; 500-11-44B, 44mm; 500-11-46C, 46mm; 500-11-48D, 48mm; 500-11-50D, 50mm; 500-11-52E, 52mm; 500-11-54E, 54mm; 500-11-56F, 56mm; 500-11-58-F, 58mm; 500-11-60G, 60mm; 500-11-62G, 62mm; 500-11-64H, 64mm; 500-11-66H, 66mm; 500-11-681, 68mm; 500-11-701, 70mm; 500-11-72J, 72mm; 500-11-74J, 74mm, Recall # Z-1169-2008;
c) Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics; Catalog Numbers: # 502-01-42A; 42mm; 502-01-44B, 44mm; 502-01-46C, 46mm; 502-01-48D, 48mm; 502-01-50D, 50mm; 502-01-52E, 52mm; 502-01-54E, 54mm; 502-01-56F, 56mm; 502-01-58F, 58mm;, 502-01-60G, 60mm; 502-01-62G, 62mm; 502-01-64H, 64mm; 502-01-66H, 66mm; 502-01-681, 68mm; 502-01-701, 70mm;, 502-01-72J, 72mm; 502-01-74J, 74mm, Recall # Z-1170-2008;
d) Trident Hemispherical HA Cluster, 42 mm - 74mm Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Catalog Numbers: 502-11-42A, 42mm;502-11-44b, 44mm; 502-11-46C, 46mm; 502-11-48D, 48mm; 502-11-50D, 50mm; 502-11-52E, 52mm; 502-11-54E, 54mm; 502-11-56F, 56mm; 502-11-58F, 58mm; 502-11-60G, 60mm; 502-11-62G, 62mm; 502-11-64H, 64mm; 502-11-66H, 66mm; 502-11-68I, 68mm; 502-11-70I, 70mm; 502-11-72J. 72mm; 502-11-74J, 74mm, Recall # Z-1171-2008;
e) Trident Hemispherical Multi Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Catalog Numbers: 500-11-42A; 508-11-4B; 508-11-46C; 508-11-48D; 508-11-50D; 508-11-52E; 508-11-54E; 508-11-56F; 508-11-58F; 508-11-60G; 508-11-62G; 50811-64H; 508-11-66H; 508-11-68I; 508-11-70I; 598-11-72J; 508-11-74J, Recall # Z-1172-2008;
f) Trident PSL Acetabular Shells; Trident PSL HA Solid Back, 40 mm to 73 mm, hip prosthesis component, Stryker Orthopaedics, 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 2469501A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3324601A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3324601C 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3383201A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3452701A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1233601C 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 1233601E 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1266301A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 2469901A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 2469902A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 3383301A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 3383301C 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 3452801A 540-11-44C TRIDENT PSL HA SOLID BACK 44mm 2468301A 540-11-44C
TRIDENT PSL HA SOLID BACK 44mm 2468301D 540-11-44C TRIDENT PSL HA SOLID BACK 44mm 2485601A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2444801A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2468401A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2468401D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2517201A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2517201D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2549701A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919001A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919001D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919002A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919002D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919003A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919103A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919104A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919104D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104101A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102E 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104103A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3452501A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468501A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468502A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468503A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468503D 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483101A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102C 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102D 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2863001A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2863002A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2954001A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 3088702A 540-11-50E
TRIDENT PSL HA SOLID BACK 50mm 2483203A 540-11-50E TRIDENT PSL HA SOLID BACK 50mm 2825801A 540-11-50E
TRIDENT PSL HA SOLID BACK 50mm 2925906A 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 2518502A 540-11-52E
TRIDENT PSL HA SOLID BACK 52mm 2713204A 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 2926107A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2518601A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2926001A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2926003A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2926008A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2483301A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2518702A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2518704A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2713502A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 3118502A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2468901A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2468902A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2484905A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2518802A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2941802A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469001A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469002A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469002C 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469003A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469003D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2483602A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2483602D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2517702A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2650601A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2826401C 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2826401D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941901A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941901D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941902A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941903A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701E 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483702C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517601A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517602A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517602D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517603A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2650701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2910701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949801A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701E 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3088802A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 3088802D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3118802A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2445001A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2445001D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483901A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902C 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902E 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902F 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2503601A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2551101A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2551101D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801C 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2734501A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911301A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911302A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911303A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2953801A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2953801D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3233702A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3233704A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3712001A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101C 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101D 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101E 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2484501A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2484501C 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2484501E 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2517401A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2551301A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2650901A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2650901C 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2910902A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2910903A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2910904A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2990801A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2445201A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2445201D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2445202A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701E 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484702A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2517501A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2517501C 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2517501D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001F 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2657801A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2657801C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2657801D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911001A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911001D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911001E 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911002A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911003A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911003D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911004A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911004D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911005A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911005D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2551901A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2551901D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2651101A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2651101C 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2651101D 540-11-70J RIDENT PSL HA SOLID BACK 70mm 2911102A 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2911102C 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2911102D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 3000001A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 3000001D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 5334001A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2503501A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2552201A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2552201C 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2552201D 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2651201A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2651201C 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2911201A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 3000101A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 3452901A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 3452901D, Recall # Z-1173-2008;
g) Trident PSL HA Cluster: 40 mm to 72 mm, hip prosthesis component,
540-11-40A TRIDENT PSL HA SOLID BACK 40mm 2469501A 540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 3324601A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3324601C 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3383201A 540-11-40A TRIDENT PSL HA SOLID BACK 40mm 3452701A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1233601C 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 1233601E 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 1266301A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 2469901A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 2469902A 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 3383301A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 3383301C 540-11-42B TRIDENT PSL HA SOLID BACK 42mm 3452801A 540-11-44C
TRIDENT PSL HA SOLID BACK 44mm 2468301A 540-11-44C TRIDENT PSL HA SOLID BACK 44mm 2468301D 540-11-44C
TRIDENT PSL HA SOLID BACK 44mm 2485601A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2444801A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2468401A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2468401D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2517201A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2517201D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2549701A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919001A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919001D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919002A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919002D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919003A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919103A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919104A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 2919104D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104101A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102A 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102D 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104102E 540-11-46D TRIDENT PSL HA SOLID BACK 46mm 3104103A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3452501A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468501A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468502A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468503A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2468503D 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483101A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102C 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2483102D 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2863001A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2863002A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 2954001A 540-11-48D TRIDENT PSL HA SOLID BACK 48mm 3088702A 540-11-50E TRIDENT PSL HA SOLID BACK 50mm 2483203A 540-11-50E
TRIDENT PSL HA SOLID BACK 50mm 2825801A 540-11-50E TRIDENT PSL HA SOLID BACK 50mm 2925906A 540-11-52E
TRIDENT PSL HA SOLID BACK 52mm 2518502A 540-11-52E TRIDENT PSL HA SOLID BACK 52mm 2713204A 540-11-52E
TRIDENT PSL HA SOLID BACK 52mm 2926107A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2518601A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2926001A 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 2926003A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2926008A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2483301A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2518702A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 2518704A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2713502A 540-11-56F TRIDENT PSL HA SOLID BACK 56mm 3118502A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2468901A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2468902A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2484905A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2518802A 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 2941802A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469001A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469002A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469002C 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469003A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2469003D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2483602A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2483602D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2517702A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2650601A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2826401C 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2826401D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941901A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941901D 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941902A 540-11-60G TRIDENT PSL HA SOLID BACK 60mm 2941903A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483701E 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483702A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2483702D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517601A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517602A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517602D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2517603A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2650701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2910701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949801A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802C 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2949802D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 2995701E 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 3088802A 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3088802D 540-11-62H TRIDENT PSL HA SOLID BACK 62mm 3118802A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2445001A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2445001D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483901A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902C 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2483902E 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483902F 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2503601A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2551101A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2551101D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801C 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2650801D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2734501A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911301A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911302A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2911303A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2953801A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 2953801D 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3233702A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3233704A 540-11-64H TRIDENT PSL HA SOLID BACK 64mm 3712001A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101C 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101D 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2445101E 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2484501A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2484501C 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2484501E 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2517401A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2551301A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2650901A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2650901C 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2910902A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2910903A 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 2910904A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2990801A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2445201A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2445201D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2445202A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701C 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2484701E 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484702A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2517501A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2517501C 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2517501D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001C 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2651001F 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2657801A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2657801C 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2657801D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911001A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911001D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911001E 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911002A 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911003A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911003D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911004A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911004D 540-11-68I TRIDENT PSL HA SOLID BACK 66mm 2911005A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911005D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2551901A 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2551901D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2651101A 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2651101C 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2651101D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2911102A 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 2911102C 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2911102D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 3000001A 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 3000001D 540-11-70J TRIDENT PSL HA SOLID BACK 70mm 5334001A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2503501A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2552201A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2552201C 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2552201D 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2651201A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 2651201C 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2911201A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 3000101A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 3452901A 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 3452901D
Recall # Z-1174-2008

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on January 21, 2008, February 4, and February 28, 2008.

Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.

REASON: Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 11, 2008:

CLASS II

PRODUCT: ADVIA Centaur Tnl-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Recall # Z-0580-2008

MANUFACTURER: Recalling Firm: Siemens Medical Solutions Diagnostics, Tarrytown, NY, by e-mail on June 7, 2007 and July 5, 2007. Manufacturer: Siemens Medical Solutions Diagnostics, East Walpole, MA. Firm initiated recall is ongoing.

REASON: Incorrect results: Falsely elevated Troponin values have been reported which are inconsistent with the patient's clinical picture and test negative by other Troponin assays.

PRODUCT: GE Healthcare Proteus XR/a Radiographic System, Model Number 2259976; previously marketed as the Silhouette FC, Recall # Z-0842-2008

MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by a Field Modification Instruction and visit beginning December 2007. Manufacturer: GE Hangwei Medical Systems Co LTD, Beijing Econ & Tech Dev Zone, China. Firm initiated recall is ongoing.

REASON: The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976.

PRODUCT:
a) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Recall # Z-0905-2008;
b) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Recall # Z-0906-2008;
c) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Recall # Z-0907-2008;
d) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Recall # Z-0908-2008;
e) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Recall # Z-0909-2008;
f) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Recall # Z-0910-2008;
g) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Recall # Z-0911-2008;
h) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Recall # Z-0912-2008;
i) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Recall # Z-0913-2008

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on November 29, 2007. Manufacturer: Onset Medical Corporation, Irvin, CA. Firm initiated recall is ongoing.

REASON: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.

PRODUCT: AMO VISX STAR Excimer Laser System 0030-4864 Chair component of the System 0030-2381. Each chair also has a serial number, which is the same as the serial number assigned to the system it is part of, Recall # Z-1139-2008

MANUFACTURER: VISX Incorporated, a Subsidiary of AMO Inc., Santa Clara, CA, by letter on December 13, 2007. Firm initiated recall is ongoing.

REASON: Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS laser.

PRODUCT: B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, Recall # Z-1140-2008

MANUFACTURER: Recalling Firm: B & K Medical Systems, Inc., Wilmington, MA, by letter on January 23, 2008. Manufacturer: B-K Medical A/S, Herlev, Denmark. Firm initiated recall is ongoing.

REASON: Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.

PRODUCT:
a) CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. Catalog Number REF SU-20601; Recall # Z-1175-2008;
b) CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; Catalog Number REF SU-20602; Recall # Z-1176-2008;
c) CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. Catalog Number REF SU-20802; Recall # Z-1177-2008

MANUFACTURER: California Medical Laboratories, Inc., Costa Mesa, CA, by letters on January 24, 2008. Firm initiated recall is ongoing.

REASON: Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.

PRODUCT: Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged in rigid styrene roll stock with a tyvek top, 50 units per case; Catalog #SSI-0003; Recall # Z-1178-2008

MANUFACTURER: Recalling Firm: Cardinal Health, McGaw Park, IL, by letter dated February 12, 2008. Manufacturer: Convertors De Mexico, S.A. De C.V., Ciudad, Juarez, Mexico. Firm initiated recall is ongoing.
REASON: The product has the potential of being non-sterile.

PRODUCT:
a) U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. Recall # Z-1710-2008
b) Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Unit), (2) Alaris Pump Module (Model 8100) (a.k.a. Medley Pump Module), (3) Alaris Syringe Module (Model 8110)
(a.k.a. Medley Syringe Module), (4) Alaris PCA Module (Model 8120) (a.k.a. Medley PCA Module), (5) Alaris SpO2 Module (Models 8210) (a.k.a. Medley SpO2 Module) with Nellcor technology, and (6) Alaris SpO2 Module (Models 8220) (a.k.a. Medley SpO2 Module) with Masimo technology, Recall # Z-1711-2008;
c) U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe module) (2) Alaris PCA module (Model 8120) (a.k.a. Medley PCA module), Recall # Z-1712-2008

MANUFACTURER: Recalling Firm: Cardinal Health 303 Inc., dba Alaris Products, San Diego, CA, by letter on April 10, 2008. Manufacturer: Cardinal Health 303 dba Cardinal Health, San Diego, CA. Firm initiated recall is ongoing.

REASON:
a) A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failures of the U19 Socketed Integrated Circuits (U19 IC) on the logic board of the Alaris Pump module ("Pump module"). The user will be required to replace the affected module.
b) A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface (IUI) connectors on all Alaris System modules (manufactured on or before March 26, 2004). Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004:
(1) Alaris PC point-of-care unit ("PC Unit") (Model 8000)* (a.k.a. Medley PC Unit),
(2) Alaris Pump Module (Model 8100) (a.k.a. Medley Pump Module),
(3) Alaris Syringe Module (Model 8110) (a.k.a. Medley Syringe Module),
(4) Alaris PCA Module (Model 8120) (a.k.a. Medley PCA Module),
(5) Alaris SpO2 Module (Models 8210) (a.k.a. Medley SpO2 Module) with Nellcor technology, and
(6) Alaris SpO2 Module (Models 8220) (a.k.a. Medley SpO2 Module) with Masimo technology. The user will be required to replace the affected module.
c) A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the Alaris Syringe Module ("Syringe module") and Alaris PCA module ("PCA module") for modules manufactured on or before October 4, 2005. The user will be required to replace the affected module.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 4, 2008:

CLASS II
PRODUCT: MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361, Recall # Z-1137-2008
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated November 28, 207. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON: Delay in Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. Fluoroscopy cannot be performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. The loss of system availability could occur during an interventional procedure if the user conducts these housekeeping functions at that time.

CLASS III
PRODUCT: Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Recall # Z-0300-2008
MANUFACTURER: Ventana Medical Systems, Tucson, AZ, by visit on 9/6/07. Firm initiated recall is complete.
REASON: Shock hazard: Devices released prior to full testing; the configuration of the Symphony instrument during Hi pot testing procedures did not completely evaluate all components in the test loop. In specific circumstances, a shock hazard exists.

PRODUCT: Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002, Recall #
Z-1546-2008
MANUFACTURER: Lorad, A Hologic, Inc., Danbury, CT, by letter on March 21, 2008. Firm initiated recall is ongoing.
REASON: Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indication.

PRODUCT: EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1., Recall # Z-1644-2008
MANUFACTURER: Emageon, Inc., Hartland, WI, by letters on January 9, and January 18, 2008. Firm initiated recall is ongoing.
REASON: Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. The calculation error exists in both the software and user guide.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 28, 2008

CLASS II
PRODUCT:
a) Synchron LX20 Clinical Chemistry System, Part Numbers: 466200,473032, Recall # Z-1094-2008;
b) Synchron LX20 PRO, Part Number 476100, Recall # Z-1095-2008;
c) Synchron LXi 725, Part Number A08357, Recall # Z-1096-2008;
d) UniCel DxC 600 Part Number: A10405, Recall # Z-1097-2008;
e) UniCel DxC 600i, Part Numbers: A25638, A25639, Recall # Z-1098-2008;
f) UniCel DxC 600 PRO Part Number: A10400, Recall # Z-1099-2008;
g) UniCel DxC 800 Part Number: A10411, Recall # Z-1100-2008;
h) UniCel DxC 800 PRO Part Number: A10407, Recall # Z-1101-2008
MANUFACTURER: Beckman Coulter Inc, Brea, CA, decided that Customer Notification is not needed. Replacements began April 5, 2007. Firm initiated recall is ongoing.
REASON: Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags or motion errors. -If a stall occurs during a GLUm test near the time of sample inject, results may be affected. -Affected GLUm results may be high or low.

PRODUCT:
a) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Recall # Z-1110-2008;
b) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro diagnostic, Recall # Z-1111-2008;
c) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro diagnostic, Recall # Z-1112-2008;
d) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 504 ml, Catalog no. HA926-504, in vitro diagnostic, Recall # Z-1113-2008;
e) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Recall # Z-1114-2008;
f) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Recall # Z-1115-2008;
g) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 8-A7526-R1-120, in vitro diagnostic, Recall # Z-1116-2008;
h) Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 305 ml, Catalog no. HA 726-305, in vitro diagnostic, Recall # Z-1117-2008
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letters dated December 14, 2007. Firm initiated recall is ongoing.
REASON: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.

PRODUCT: Keeler All Pupil II Indirect Ophthalmoscope, Recall # Z-1132-2008
MANUFACTURER: Recalling Firm: Keeler Instruments, Inc., Broomall, PA, by email dated January 8, 2008. Manufacturer: Keeler Limited, Windsor, UK. Firm initiated recall is ongoing.
REASON: Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.

CLASS III
PRODUCT: Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Recall # Z-1166-2008
MANUFACTURER: Abbott Laboratories, Inc, Irving, TX, by letter dated September 26, 2007. Firm initiated recall is ongoing.
REASON: Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the interferent affects Potassium (K+) only. Use of the affected calibrator vials will generate an acceptable, but low calibration slope. When Quality Control (QC) is run to verify the calibration, K+ QC results may be below acceptable QC ranges. This interferent does not affect Sodium (Na+) and Chloride (CL-).

PRODUCT: MT-APSD-2.4 Type-@ Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package, Recall # 1608-2008
MANUFACTURER: Recalling Firm: Civco Medical Instruments Inc, Kalona, IA, by letter on February 25, 2008. Manufacturer: Med Tec Inc dba CIVCO Medical Solutions, Orange City, IA. Firm initiated recall is ongoing.
REASON: Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.

PRODUCT:
a) Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, Recall # Z-1613-2008;
b) Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-809, Recall # Z-1614-2008
MANUFACTURER: Recalling Firm: Med Tec Inc dba CIVCO Medical Solutions, Orange City, IA, by telephone beginning February 28, 2008 and letter on February 29, 2008. Manufacturer: C P Medical, Portland, OR. Firm initiated recall is ongoing.
REASON: Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers.

PRODUCT: 9051 Electrode Adapter; Automated external defibrillator, Used with QUIK-COMBO System; Recall # Z-1616-2008
MANUFACTURER: Cardiac Science Corp, Bothell, WA, by letter on January 23, 2008. Firm initiated recall is ongoing.
REASON: Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 21, 2008

CLASS II
PRODUCT:
a) VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version), Recall # Z-0982-2008;
b) VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version), Recall # Z-0983-2008;
c) VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version), Recall # Z-0984-2008;
d) VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version), Recall # Z-0985-2008;
e) VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version), Recall # Z-0986-2008
MANUFACTURER: Viasys Respiratory Care, Inc. dba Bird Products, Palm Springs, CA, by letters on December 18, 2007. Firm initiated recall is complete.
REASON: Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.

PRODUCT: AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure device, which is part of a larger system that includes an Infant Nasal CPAP generator, fixation device and patient interface (prongs and/or mask); Firmware Version 2.02.39, Recall # Z-0987-2008
MANUFACTURER: Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letter dated January 4, 2008. Manufacturer: Cardinal Health 200 Inc dba Cardinal Health, Riverside, CA. Firm initiated recall is ongoing.
REASON: Oxygen fluctuations - The AirLife Infant Nasal CPAP System exhibited O2 fluctuations when used with low O2 flow rates when the PTO/Auxiliary port on the driver is used as a blender in administering O2 therapy via nasal cannula at flow rates of less than 4L/min.

PRODUCT: White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Recall # Z-1103-2008
MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letter on December 19, 2007. Firm initiated recall is ongoing.
REASON: Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

PRODUCT: Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Recall # Z-1105-2008
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on February 25, 2005. Firm initiated recall is complete.
REASON: Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.

PRODUCT: Syngo US Workplace Picture Archiving and Communication System, software version 2.0, 94043. Material number: 10035829, Recall # Z-1138-2008
MANUFACTURER: Siemens Medical Solutions, Inc., Mountain View, CA, by letter dated November 2007. Firm initiated recall is ongoing.
REASON: Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.

CLASS III
PRODUCT: Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable, Recall # Z-1461-2008
MANUFACTURER: Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, by fax on March 7, 2007. Manufacturer: Alcon Grieshaber AG, Schaffhausen, Switzerland. Firm initiated recall is ongoing.
REASON: Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.

PRODUCT: AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08, Recall # Z-1462-2008
MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by letter on January 21, 2008. Firm initiated recall is ongoing.
REASON: Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.

PRODUCT:
a) Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, Recall # Z-1624-2008;
b) Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, Recall # Z-1625-2008
MANUFACTURER: Remel Inc, Lenexa, KS, by letter on October 23, 2007. Firm initiated recall is complete.
REASON: Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 14, 2008

CLASS II
PRODUCT: Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers 9012B1011 and 9012B1001, Recall # Z-0517-2008
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter in December 2007. Manufacturer: Arizona Device Mfg., Tempe AZ. Firm initiated recall is ongoing.
REASON: Unable to detach from source: The capsule may not detach from the delivery system following attachment to the esophageal wall.

PRODUCT: Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O, Recall # Z-1118-2008
MANUFACTURER: Recalling Firm: Innovacon Inc., San Diego, CA, by letter dated October 1, 2007. Manufacturer: Abon Biopharm (Hangzhou) Co., Ltd, Hangzhou, Zhejiang, China. Firm initiated recall is ongoing.
REASON: Incorrect results; The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user.

PRODUCT: ADVIA Centaur HAV lgM, 100 Test Kit, used on the ADVIA Centaur or XP, REF: 05004126, in vitro diagnostic Hepatitis A test, Recall # Z-1119-2008
MANUFACTURER: Siemens Medical Solutions Diagnostics, East Walpole, MA, by letter on January 12, 2008. Firm initiated recall is ongoing.
REASON: Incorrect results; False reactive specimens on the ADVIA Centaur HAV lgM assay.

PRODUCT:
a) ev3 IntraStent Biliary Stent, Model Number: S10-26, Catalog Number: 90-0648-001, Recall # Z-1120-2008;
b) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, Catalog Number: 90-0952-000, Recall # Z-1121-2008;
c) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, Catalog Number: 90-0952-001, Recall # Z-1122-2008;
d) ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, Catalog Number: 90-0952-002. ev3 IntraStent DoubleStrut Peripheral Stent, Model Number: S11-36, Catalog Number: 90-1075-002 (not approved within the USA), Recall # Z-1123-2008;
e) ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16, Catalog Number: 90-1431-000. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-16, Catalog Number: 90-1504-000 (not approved within USA), Recall # Z-1124-2008;
f) ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, Catalog Number: 90-1431-002. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-36, Catalog Number: 90-1504-002 (not approved within USA), Recall # Z-1125-2008;
g) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16, Catalog Number: 90-2313-000 ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-16, Catalog Number: 90-2336-000 (not approved within USA), Recall # Z-1126-2008;
h) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26, Catalog Number: 90-2313-001. ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-26, Catalog Number: 90-2336-001 (not approved within USA), Recall # Z-1127-2008;
i) ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36, Catalog Number: 90-2313-002. ev3 IntraStent LD Mega Large Diameter Peripheral Stent, Model Number: S17-36, Catalog Number: 90-2336-002 (not approved within USA), Recall # Z-1128-2008;
j) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, Catalog Number: 90-2319-000. ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-16, Catalog Number: 90-2337-000 (not approved within USA), Recall # Z-1129-2008;
k) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, Catalog Number: 90-2319-001. ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-26, Catalog Number: 90-2337-001 (not approved within USA), Recall # Z-1130-2008;
l) ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, Catalog Number: 90-2319-002. ev3 IntraStent LD Max Large Diameter Peripheral Stent, Model Number: S18-36, Catalog Number: 90-2337-002. (not approved within USA), Recall # Z-1131-2008
MANUFACTURER: Ev3, Inc., Plymouth, MN, by letter on January 18, 2008. Firm initiated recall is ongoing.
REASON: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.

PRODUCT: iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Recall # Z-1141-2008
MANUFACTURER: Philips Healthcare Informatics, Inc., Foster City, CA, by letter on January 21, 2008. Firm initiated recall is ongoing.
REASON: Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.

PRODUCT:
a) Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 100 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection. The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations:
a) NDC #64253-333-35, catalog #MIH-3335: 5 mL fill in 12 mL syringe,
b) NDC #64253-333-33, catalog #MIH-3333: 3 mL fill in 12 mL syringe,
c) NDC #64253-333-23, catalog #MIH-3323: 3 mL fill in 6 mL syringe, Recall # Z-1543-2008;

b) Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection. The pre-filled syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations:
a) NDC #64253-222-35, catalog #MIH-2235: 5 mL fill in 12 mL syringe;
b) NDC #64253-222-33, catalog #MIH-2233: 3 mL fill in 12 mL syringe, Recall # Z-1544-2008;

c) Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 unit of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; The 5 mL fill in 6 mL syringes were packed 60 syringes per dispenser box,
16 boxes per shipping carton, NDC #64253-444-25, catalog #MIH-4425, Recall # Z-1545-2008

MANUFACTURER: Medefil, Inc., Glendale Heights, IL, by telephone on March 20, 2008, and by e-mail and letter on March 21, 2008 and March 24, 2008. Firm initiated recall is ongoing.
REASON: The heparin lock flush solution was manufactured from contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API). The FDA has received reports of serious injuries and/or deaths in patients administered finished heparin injectable products manufactured from heparin API containing this contaminant.

PRODUCT:
a) Tyco Healthcare Monoject Prefill 10U/rnL Heparin Lock Flush Syringe, 10ml, REF # 8881580121, Recall # Z-1594-2008;
b) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123, Recall # Z-1595-2008;
c) Tyco Healthcare Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL REF # 8881580125, Recall # Z-1596-2008;
d) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 2.5mL in 3mL syringe REF # 8881580300, Recall # Z-1597-2008;
e) Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881581125, Recall # Z-1598-2008;
f) Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 10mL REF # 8881590121, Recall # Z-1599-2008;
g) Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL REF # 8881590123, Recall # Z-1600-2008;
h) Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL REF # 8881590125, Recall # Z-1601-2008;
i) Tyco Healthcare Monoject Prefill 100UlmL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881591125, Recall # Z-1602-2008
MANUFACTURER: Recalling Firm: Covidien LP, Mansfield, MA, by letter beginning March 28, 2008, through April 1, 2008. Manufacturer: Covidien, Montreal, Quebec, Canada. Firm initiated recall is ongoing.
REASON: Scientific Protein Laboratories (SPL) disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient have a heparin-like contaminant.

CLASS III
PRODUCT:
a) Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, Recall # Z-1035-2008;
b) Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, Recall # Z-1036-2008
MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter dated December 12, 2007. Manufacturer: B. Braun Carex SpA, Mirandola (MO), Italy. Firm initiated recall is ongoing.
REASON: Faulty tubing does not prime machine as intended.

PRODUCT: Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, UPC Code: 30003-020917 and UPC Code: 30003-020917, Recall # Z-1179-2008
MANUFACTURER: Recalling Firm: ConvaTec, Skillman, NJ, by letters on February 14, 2008, February 21, 2008 and April 10, 2008. Manufacturer: Nypro Dominican Republic, Inc., San Cristobal, Dominican Republic. Firm initiated recall is ongoing.
REASON: Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.

PRODUCT: LIASON® 25-OH Vitamin D Kit, Vitamin D test system, Model Number 310900, Recall # Z-1240-2008
MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter sent by e-mail on February 1, 2008. Firm initiated recall is ongoing.
REASON: Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.

PRODUCT:
a) Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft length, 90 cm, Catalog Number: 34356-446, UPN H749343564460, Sterile EO, Recall # Z-1300-2008;
b) Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in (internal dia), Shaft length 55cm, Catalog Number: 19-600, UPN M001196000, Sterile EO, Recall # Z-1301-2008;
c) Boston Scientific Mach 1 peripheral Guide Catheter 6F, MP Multipurpose 90cm,.070 in (internal dia), Shaft length 90cm, Catalog Number: 19-626, UPN M001196260, Sterile EO, Recall # Z-1302-2008;
d) Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve, .070 in (internal dia), Shaft length 55cm, Catalog Number: 19-666, UPN M001196660, Sterile EO, Recall # Z-1303-2008;
e) Boston Scientific Mach 1 peripheral Guide Catheter 7F, MP Multipurpose, .081 in (internal dia), Shaft length 55cm, Catalog Number: 19-723, UPN M001197230, Sterile EO, Recall # Z-1304-2008;
f) Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft length 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Recall # Z-1305-2008
MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on February 7, 2008. Manufacturer: Availmed S.A. de CV, Tijuana, Mexico. Firm initiated recall is ongoing.
REASON: Mislabeled: Seven lots/batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 7, 2008

CLASS II
PRODUCT:
a) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Recall # Z-0905-2008;
b) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Recall # Z-0906-2008;
c) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Recall # Z-0907-2008;
d) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Recall # Z-0908-2008;
e) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Recall # Z-0909-2008;
f) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Recall # Z-0910-2008;
g) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Recall # Z-0911-2008;
h) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Recall # Z-0913-2008
MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on November 29, 2007. Manufacturer: Onset Medical Corporation, Irvine, CA. Firm initiated recall is ongoing.
REASON: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.

PRODUCT:
a) Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle radiation therapy system with software version 2.1, Recall # Z-0971-2008;
b) Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1, Recall # Z-0972-2008;
c) Siemens Coherence Impression Therapist system, Part No: 7341410, medical charged-particle radiation therapy system with software version 2.1, Recall # Z-0973-2008;
d) Siemens Primeview 3i medical charged-particle radiation therapy system, Part No: 7341428, with software version 3i, Recall # Z-0975-2008;
e) Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345411, Recall # Z-0975-2008;
f) Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345429, Recall # Z-0976-2008;
g) Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation therapy system, Part No: 7345437, Recall # Z-0977-2008;
h) Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy system, Part No: 8139839, with software version 2.1, Recall # Z-0978-2008;
i) Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No: 8139487, with software version 3i 2.0, Recall # Z-0979-2008;
j) Siemens Coherence Therapist 2.1 medical charged-particle radiation therapy system, Part No: 8147667, with software version 2, Recall # Z-0980-2008;
k) Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part No: 8147675, with software version 3i, Recall # Z-0981-2008
MANUFACTURER: Siemens Medical Solutions, USA, Inc., Concord, CA, by letter on October 3, 2007. Firm initiated recall is ongoing.
REASON: Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference image will shift.

PRODUCT: Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Recall # Z-1038-2008
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated December 21, 2007 Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON: Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.

PRODUCT : Seradyn QMS Vancomycin reagents, Part Number: 0373589, Recall # Z-1102-2008
MANUFACTURER: Seradyn, Inc., Indianapolis, IN, by letter dated December 20, 2007. Firm initiated recall is ongoing.
REASON: False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.

PRODUCT: GE Centricity PACS RA1000 Workstation; for diagnostic image analysis, Recall # Z-1104-2008
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated December 28, 2007. Firm initiated recall is ongoing.
REASON: Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open.

PRODUCT: Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Recall # Z-1106-2008
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corporation, Portage, MI, by letter dated January 10, 2008. Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
REASON: Sterility may be compromised, as the packaging may have channels in the packaging seal.

CLASS III
PRODUCT: Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Recall # Z-0912-2008
MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on November 29, 2007. Manufacturer: Onset Medical Corporation, Irvine, CA. Firm initiated recall is ongoing.
REASON: Sheath Removal Difficulty: Users experience difficulty in removing the sheath.

PRODUCT:
a) Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Recall # Z-0958-2008;
b) Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Recall # Z-0959-2008
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on June 29, 2007. Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is complete.
REASON: Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.

PRODUCT: Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Recall # Z-1037-2008
MANUFACTURER: Recalling Firm: Straumann Usa, Llc, Andover, MA, by letter on January 10, 2008. Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.
REASON: Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 30, 2008

CLASS II
PRODUCT: ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, a) Material Number 8245875; b) Material Number 8246951; c) Material Number 8267697; Recall Z-0661-2008
MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on September 25, 2007. Firm initiated recall is ongoing.
REASON: Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia" system is operating at a software revision below 8.0. 2) The Sequoia" system is configured to PAL video mode (normal for systems running at 240V 50 Hz.). 3) While using any of the Perspective" advanced display options listed above, an image or clip is then stored or saved to the system hard drive, MOD or a storage device. (This image or clip is known as a secondary capture.). 4) The secondary capture images/clips are subsequently recalled for review and measurements are made. If a measurement is taken on these secondary capture images/clips, an error can occur. The error is 0% if taken in the same axis that calibration was performed, and ranges proportionately up to 9% if the measurement is taken orthogonal or at right angles (90 degrees) to the axis that was used for calibration. If calibration was done on the horizontal axis, then vertical measurements are underestimated. If calibration was done on the vertical axis, then horizontal measurements are overestimated.

PRODUCT:
1) BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1055-2008;
2) Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model number 1039618; b) filter reusable PLV 2/pkg model number 35220;
c) LX UL Fine Filter 2 pack model number 1006193;
d) RP-M Series Ultrafine Filters 6 pack model number 1029331;
e) RP Vision OM Reg Filter (ASCO) model number 1007547; and f) REPL Filters package of 4 model number 929-4. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1056-2008;
3) Non-continuous ventilator accessories under the following brand names:
a) Adult ECG Electrodes model number 1016360;
b) O2 Enrichment Attachment BX 10 model number 312010;
c) O2 Enrichment Attachment Single model number 312710;
d) Alice 5, Domestic model number 1017226;
e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS;
f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS;
g) BIPAP Auto M, W/SmartCard, US model number DS700S;
h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716;
i) BIPAP Harmony, Intl model number 1012823;
j) BIPAP Plus M, US model number DS600;
k) BIPAP Plus M, W/Humid US model number DS600H;
l) BIPAP S/T Core Pkg NA model number 1014248;
m) BIPAP S/T North America model number 1012885;
n) BIPAP Vision Filter Pack model number 582101;
o) Duet LX/BIPAP Pro/Synch Pollen QTY 1 model number 1039611;
p) FLXTB, 5 ½ inch STD, 22 mm, CE model number 1006042;
q) FLXTB, 6 in Trach 15 mm taper, CE model number 1004968;
r) GP UL-Fine Filter 2 pack model number 1006190;
s) Incoming Filter 7000, 7001 CPAP model number 7070;
t) Infant ECG Electrodes model number 1016361.
Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1057-2008;
4) Inv Circuit Assembly Box 10 CE model number 652002. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1058-2008;
5) M Series Heated Humidifier Domestic model number 1022257. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1059-2008;
6) Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1060-2008;
7) Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1061-2008;
8) PLV-102, 100V 50/60 HZ Japanese model number 87006. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1062-2008;
9) Power Cord Accessory under the following brand names: a) Power Cord W/C7 End Europe 5 ft model number 1039014 and b) Power Cord W/C7 End USA/CAN model number 1005894. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1063-2008;
10) Non-continuous ventilators accessories under the following brand names:
a) REM Auto M. w/Humid, w/Smartcard A Flex US model number DSS10HS;
b) REM Auto M. w/SC, w/Humid A Flex CAN model number CA511HS. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1064-2008;
11) Non-continuous ventilator accessories under the following brand names:
a) REMStar (Tower) Ultrafine Qty 1 model number 1036915,
b) REMStar Auto M. w/Humid. w/Smartcard. US model number DS500HS;
c) REMStar Auto M. w/Smartcard A FLEX US model number DS510S;
d) REMStar Auto M. w/Smartcard, CNDA model number CA501S;
e) REMStar Auto M w/Smartcard Intl model number IN501S;
f) REMStar Auto M w/Smartcard US model number DS500S;
g) REMStar Auto w/C-FLEX CANADA model number CA1017454;
h) REMStar Auto w/C-FLEX Domestic Core Pkg model number 1017476. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1065-2008;
12) REMStar Heated Humidifier Pkg model number 1005792. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1066-2008;
13) Non-continuous ventilator accessories under the following brand names:
a) REMStar M US model number DS100;
b) REMStar M w/Humid US model number DS100H. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1067-2008;
14) Non-continuous ventilator accessories under the following brand names:
a) REMStar Plus M US model number DS200;
b) REMStar Plus M w/Humid AHP model number AHP200H;
c) REMStar Plus M w/Humid US model number DS200H;
d) REMStar Plus M w/Humid, w/Smartcard, AHP model number AH200HS;
e) REMStar Plus M w/Smartcard, US model number DS200S;
f) REMStar Plus w/C Flex Dom model number 1009586. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1068-2008;
15) Non-continuous ventilator accessories under the following brand names:
a) REMStar Pro2 Domestic model number 1020923;
b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS;
c) REMStar Pro M w/Smartcard US model number DS400S;
d) REMStar Pro/Plus Silencer Cap model number 1005962;
e) REMStar Pro/Plus/Auto/Lite Pollen model number 1005964;
f) REMStar Pro/Plus/Auto/Lite Pollen SNGL model number 1001389;
g) REMStar Pro/Plus/Auto/Lite Ultrafine model number 1005945;
h) REMStar Pro/Plus/Auto/Lite Ultrafine Qty 1 model number 1039607. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1069-2008;
16) Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1070-2008
17) Non-continuous ventilator accessories under the following brand names:
a) RP-L ComfortGel Cush and Flap model number 1031404;
b) RP-M ComfortGel Cush and Flap model number 1031403. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1071-2008;
18) RP M Series Pollen Filter Kit 1 pack model number 1035443, Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1072-2008;
19) Non-continuous ventilator accessories under the following brand names:
a) RP-P ComfortGel Cush and Flap model number 1031391 and b) RP-S ComfortGel Cush and Flap model number 1031392. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1073-2008;
20) Power Supply under the following brand names:
a) RP, Power Supply Assembly model number H3600-015,
b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1074-2008;
21) RP-Assy, Cover, DC-5 pack model number F35933. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1075-2008;
22) Non-continuous ventilator accessories under the following brand names:
a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185;
b) RP-BIPAP M Series Keypad model number 1038122; and
c) RP-BIPAP Pro 2 /Plus Tubing Kit model number 1020358.
Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1076-2008;
23) RP-Cable DC 6 w/Ring PLV RBL POR model number FC07270. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1077-2008;
24) RP C-Flex Mini Din Plug model number 1011220. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1078-2008;
25) Non-continuous ventilator accessories under the following brand names:
a) RP-ComfortGel Gel Cushion M model number 1009050;
b) RP-ComfortGel Gel Cushion P model number 1009048;
c) RP-ComfortGel Gel Cushion S model number 1009049;
d) RP-ComfortGel Silicone Flap L model number 1009109;
e) RP-ComfortGel Silicone Flap M model number 1009054; and
f) RP-ComfortGel Silicone Flap S model number 1009053.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1079-2008;
26) RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1080-2008;
27) RP Duet LX/Pro Out Port w/Seal model number 622239. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1081-2008;
28) RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1082-2008;
29) RP-REM Auto w/C-FLEX/REM Pro Tubing Kit model number 1008492 and RP-REM Power Cord N. AMER model number 362524. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1083-2008;
30) RP-REMStar Plus Keypad model number 1006852. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1084-2008;
31) Continuous ventilator accessories under the following brand names:
a) RP-Seal, Spring-5 pk model number F35465;
b) RP-Seal, Greece, Ballscrew model number F35036;
c) RP-Tub PVC 1/8 in x ¼ 50 ft model number 1008841;
d) RP-Vision Filter Cover model number 1003444;
e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and
f) RP-Wrap, Cord model number F35195. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1085-2008;
32) APNEA monitor accessories under the following brand names:
a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422;
b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and
c) Smartmonitor 2 with modem, PCMCIA model number 4003. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1086-2008;
33) Breathing Frequency Monitor Stardust 2 Domestic model number 1025720. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1087-2008;
34) Non-continuous ventilators under the following brand names:
a) Sync S/T Lab, w/o modem US/CAN model number 1010771;
b) Sync S/T Lab, w/o modem US/CAN-RENT model number R1010771;
c) Synchrony S w/o modem US/CAN model number 1002816;
d) Tranquility Ultrafine Qty 1 model number 1039671; and
e) Tubing Coupler model number 300065. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1088-2008;35) Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1089-2008;
36) ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1090-2008;
37) Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1091-2008;
38) Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1092-2008;
39) Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Recall # Z-1093-2008
MANUFACTURER: Respironics, Inc., Murrysville, PA, by letter dated October 18, 2007. Firm initiated recall is ongoing.

REASON: Foreign material: Glass fragments may present in the plastic bag material used to ship components.PRODUCT: CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Each package is identified with product description "CDS HGB SRNG W/BU", Recall # Z-1165-2008
MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letter on January 11, 2008 and January 15, 2008. Firm initiated recall is ongoing.
REASON: Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between May 8, 2007 and November 29, 2007.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 23, 2008:

CLASS II
PRODUCT: BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Recall # Z-0575-2008
MANUFACTURER: Bio-Rad Laboratories, Inc., Hercules, CA, by letter dated November 1, 2007, by telephone on November 13, 2007, followed up by facsimile and e-mail. Firm initiated recall is ongoing.
REASON: Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that may be slightly different from those printed on the Value Assignment Data Sheet. Some values may be identical between the lot assignment combinations with the ANA Screen with MDSS kit.

PRODUCT: Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System Proximal Femoral Resection for Large Segmental Replacements, Femur Prosthesis Surgical Literature, Recall # Z-0668-2008
MANUFACTURER: Stryker Howmedica Osteonics Corp, Mahwah, NJ, by letters on December 21, 2007 and January 7, 2008. Firm initiated recall is ongoing.
REASON: The GMRS Proximal Femoral Surgical Protocol states " The GMRS Proximal Femoral components are fully compatabile with all Stryker V40 femoral heads." This statement is incorrect and conflicts with the Alumina Head label and packaging insert.

PRODUCT:
a) Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLI-7.0-35. Recall # Z-0892-2008;
b) Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needles: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLI-7.0-35-X-1, Recall # Z-0893-2008;
c) Peel-Away Introducer set, Catheter introducer, sterile; Catalog Number: C-PLI-7.0-38-CPC-072491, Recall # Z-0894-2008;
d) Minipuncture Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 9 CM long, Wire: .025" DIA., 30 CM long, 3 MM J needle: 20XT GA., 4.0 cm long. Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLIP-7.0-25-E-MNP, Recall # Z-0895-2008;
e) Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLIP-7.0-35, Recall # Z-0896-2008;
f) Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long. Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLV-7.0-35, Recall # Z-0897-2008;
g) Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, straight. Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLV-7.0-38, Recall # Z-0898-2008;
h) Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French., sterile; Catalog Number: PLVW-7.0-35, Recall # Z-0899-2008;
i) Peel-Away Introducer set without wire guide, 7.0 FR X 15.5 CM. Catheter introducer, Accepts devices up to 7.0 French, sterile; Catalog Number: PLVW-7.0-38, Recall # Z-0900-2008;
j) Cook TPN Double Lumen Catheter set; Catheter introducer, includes 6.0 French, 65 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA., 30 CM long, Needle: 19UT Gage, 7 cm long, sterile; Catalog Number: C-TPNS-6.0D-65, Recall # Z-0901-2008;
k) Cook TPN Single Lumen Catheter set; Catheter introducer, includes 6.5 French, 90 CM Silicone Catheter, 7.0 FR. Peel-Away Introducer Set, Wire Guide: .035" DIA., 30 CM long, Needle: 18 Gage, 7 cm long, sterile; Catalog Number: C-TPNS-6.5-90-REDO, Recall # Z-0902-2008;
l) Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French, sterile; Catalog Number: C-PLI-7.0-38, Recall # Z-0903-2008;
m) Catalog Number: C-TPNS-6.5-90-REDO+. Catheter introducer, Note: This product is not distributed in the U.S. and is sent to foreign affiliates who then apply additional labeling prior to sale in their countries, Recall # Z-0904-2008
MANUFACTURER: Cook, Inc., Bloomington, IN, by letters on December 7, 2007 and December 18, 2007. Firm initiated recall is complete.
REASON: Packaging Problem: The peel-away sheath does not peel uniformly or completely.

PRODUCT:
a) BD 5 ml Syringe Luer Lok Tip Bulk Sterile Convenience Pak. Latex Free Sterile.Reorder Number: 309703, Recall # Z-0914-2008;
b) BD 10 ml Syringe Luer Lok Tip, Reorder #3039605, Recall # Z-0915-2008
MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on January 7, 2008 and January 11, 2008 Manufacturer: Becton Dickinson Medical Systems, Canaan, CT. Firm initiated recall is ongoing.
REASON: Defective Seal; The convenience trays may have open seals, which can adversely impact tray sterility.

PRODUCT:
a) Stryker Round Fluted Bur (6.0mm) Extra-Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, REF 5160-10-60, Recall # Z-0988-2008;
b) Stryker Round Fluted Bur (7.6 mm) Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, REF 5160-10-75, Recall # Z-0989-2008;
c) Stryker Round Fluted Bur (9.1 mm) Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5160-10-90, Recall # Z-0990-2008;
d) Stryker 4.7 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, REF 5160-20-47, Recall # Z-0991-2008;
e) Stryker 6.0 x 7.9 mm Fluted Drum, Extra Long for use with TPS Universal Drill Extra Long "R" Attachment, sterile, REF 5160-20-60, Recall # Z-0992-2008;
f) Stryker 10.5 x 10.7 mm Fluted Drum, Extra Long, sterile, REF 5160-20-105, Recall # Z-0993-2008;
g) Stryker 12.3 x 10.7 mm Fluted Drum, Extra Long, sterile, REF 5160-20-123, Recall # Z-0994-2008;
h) Stryker 7.5 x 7.9 mm Fluted Drum, Extra Long, sterile, REF 5160-20-775, Recall # Z-0995-2008;
i) Stryker 6.1 x 8.0 mm Acorn Bur, Extra long, sterile, REF 5160-30-60, Recall # Z-0996-2008;
j) Stryker 7.5 x 9.5 mm Acorn Bur, Extra long, sterile, REF 5160-30-75, Recall # Z-0997-2008;
k) Stryker 9.1 x 11.4 mm Acorn Bur, Extra Long, REF 5160-30-90, Recall # Z-0998-2008;
l) Stryker 3.1 mm x 19.1 mm Straight Router, Extra Long, sterile, REF 5160-70-31, Recall # Z-0999-2008;
m) Stryker Tapered Router Extra Long (2.3mm x 22.0mm) for use with extra long "R" Attachments, sterile, REF 5160-71-223, Recall # Z-1000-2008;
n) Stryker 2.0 mm x 3.8 mm Neuro Drill, Extra Long, sterile, REF 5160-107-30, Recall # Z-1001-2008;
o) Stryker 3.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-30, Recall # Z-1002-2008;
p) Stryker 4.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-40, Recall # Z-1003-2008;
q) Stryker 5.0mm Round Fluted Bur,Super Long, sterile, REF 5190-10-50, Recall # Z-1004-2008;
r) Stryker 6.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-60, Recall # Z-1005-2008;
s) Stryker 7.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-70, Recall # Z-1006-2008;
t) Stryker 8.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-80, Recall # Z-1007-2008;
u) Stryker 9.0mm Round Fluted Bur, Super Long, sterile, REF 5190-10-90, Recall # Z-1008-2008;
v) Stryker 10.0 mm Round Fluted Bur, Super Long, sterile, REF 5190-10-100, Recall # Z-1009-2008;
w) Stryker 4.0mm XX Coarse Round Diamond Bur, Super Long, sterile, REF 5190-13-140, Recall # Z-1010-2008;
x) Stryker 5.0 mm XX Coarse Round Diamond Bur, Super Long, sterile, REF 5190-13-150, Recall # Z-1011-2008;
y) Stryker 6mm XX Coarse Round Diamond Bur, Super Long, sterile, REF 5190-13-160, Recall # Z-1012-2008;
z) Stryker Instruments 7.0mm XX Coarse Round Diamond Bur, Super Long, sterile, REF 5190-13-170, Recall # Z-1013-2008;
aa) Stryker Instruments 8.omm XX Coarse Round Diamond Bur, Super Long, sterile, REF 5190-13-180, Recall # Z-1014-2008;
bb) Stryker 6.0 mm Barrel Bur, sterile, REF 5190-17-60, Recall # Z-1015-2008;
cc) Stryker 4.7mm x 7.9mm Fluted Drum, Super Long, sterile, REF 5190-20-47, Recall # Z-1016-2008;
dd) Stryker 6.0mm x 7.9 mm Bur, Super Long, sterile, REF 5190-20-60, Recall # Z-
1017-2008;
ee) Stryker 10.5mm x 10.7mm Fluted Drum, Super Long, sterile, REF 5190-20-105, Recall # Z-1018-2008;
ff) Stryker 12.3mm x 10.7mm Fluted Drum, Super Long, sterile, REF 5190-20-123, Recall # Z-1019-2008;
gg) Stryker 7.8mm x 7.9mm Fluted Drum, Super Long, sterile, REF 5190-20-775, Recall # Z-1020-2008;
hh) Stryker 9.1mm x 7.9mm Fluted Drum, Super Long, sterile, REF 5190-20-991, Recall # Z-1021-2008;
ii) Stryker 7.5mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, REF 5190-21-775, Recall # Z-1022-2008;
jj) Stryker 9.1mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, REF 5190-21-991, Recall # Z-1023-2008;
kk) Stryker 6.0mm x 8.0mm Acorn Bur, sterile, REF 5190-30-60, Recall # Z-1024-2008;
ll) Stryker 7.5mm x 9.5mm Acorn Bur, sterile, REF 5190-30-75, Recall # Z-1025-2008;
mm) Stryker 9.0mm x 11.4mm Acorn Bur, sterile, REF 5190-30-90, Recall # Z-1026-2008;
nn) Stryker 3.1mm x 19.1mm Straight Router, sterile, REF 5190-70-31, Recall # Z-1027-2008;
oo) Stryker 3.0mm x 34.9mm Straight Router, sterile, REF 5190-70-230, Recall # Z-1028-2008;
pp) Stryker 32.mm x 18.3mm Heliocoidal Rasp Super Long, for use with "RX" attachments, sterile, REF 5190-80-30, Recall # Z-1029-2008;
qq) Stryker 3.0mm x 3.8mm Precision Neuro Drill Extended Long for use with Long "AM" attachments, sterile, REF 5230-107-530S1, Recall # Z-1030-2008;
rr) Stryker 5.0mm Round Fluted Bur, Extra Long, for use with TPS Universal Drill Extra Long "R" attachment, sterile, REF 5260-10-50, Recall # Z-1031-2008;
ss) Stryker Instruments 6.5mm Round Fluted Bur Extra Long for use with TPS Universal Drill Extra Long "R" attachment, sterile, REF 5260-10-65, Recall # Z-1032-2008;
tt) Stryker Instruments 7.0mm Round Fluted Bur Extra Long, for use with TPS Universal Drill Extra Long "R" attachment, sterile, REF 5260-10-70, Recall # Z-1033-2008;
uu) Stryker Instruments Minor modification product, 550-19-20 W/ 304.8mm length, sterile, product of Ireland, REF 5500019020S3, Recall # Z-1034-2008
MANUFACTURER: Recalling Firm: Stryker Instruments, Division of Stryker Corporation, Portage, MI, by letter dated January 10, 2008. Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON: Lack of assurance of sterility.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 16, 2008:

CLASS II
PRODUCT: BD FACS Sample Prep Assistant II, Part Number: 337170, Recall # Z-0526-2008
MANUFACTURER: BD Biosciences, San Jose, Ca, by letter and on-site visit on October 1, 2007. Firm initiated recall is ongoing.
REASON: Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.

PRODUCT: Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Recall # Z-0585-2008
MANUFACTURER: Recalling Firm: Lumenis, Inc., Salt Lake City, UT, by letter on December 18, 2007, Manufacturer: Lumenis Limited, Yokneam, Israel. Firm initiated recall is ongoing.
REASON: Incorrect Label: The Units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. The micron fiber contained in the inner pouch is 200 micro fiber. The inner product is mislabeled with the wrong size.

PRODUCT:
a) Myelotec® Steerable Video Guided Catheter, 2.7mm, (product code: 2000), Recall # Z-0586-2008;
b) Myelotec® Steerable Video Guided Catheter, 3.0mm, (Product Code: 2010), Recall # Z-0587-2008
MANUFACTURER: Myelotec, Inc., Rosewell, GA, by telephone on December 19, 2007 and by letter on/about December 28, 2007. Firm initiated recall is ongoing.
REASON: Incorrect Labeling information: Product may contain inappropriate information in its label insert that refers to the product's use with energy delivering instrumentation.

PRODUCT: Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; Model Numbers Affected: All AAAdvantage models including: AEXC202040, IEXC121255, ILXC1212115, ILXC151585, AEXC222240, IEXC131355, ILXC1212135, ILXC1616115, AEXC242440, IEXC141455, ILXC121285, ILXC1616135, AEXC262640, IEXC151555, ILXC1313115, ILXC161685, AEXC282840, IEXC161655, ILXC1313135, ILXC1620115, BFXC2012135, IEXC162085, ILXC131385, ILXC1620135, BFXC2012165, IEXC181855, ILXC1414115, ILXC1818115, BFXC2213135, IEXC182285, ILXC1414135, ILXC1818135, BFXC2213165, IEXC182485, ILXC141485, ILXC181885, BFXC2414135, IEXC202055, ILXC1515115, ILXC1822115, BFXC2414165, ILXC1515135, ILXC1822135, BFXC2615135, ILXC1824115, BFXC2615165, ILXC1824135, BFXC2816135, ILXC2020115, BFXC2816165, ILXC2020135, ILXC202085; Recall # Z-0689-2008
MANUFACTURER: Medtronic CardioVascular, Santa Rosa, CA, by letters on December 7, 2007. Firm initiated recall is ongoing.
REASON: Sterility compromised: Device sterility may be compromised as evidenced by a loss of outer package integrity.

PRODUCT: ConMed Linvatec, Ultrapower Burs, Recall # Z-0711-2008
MANUFACTURER: Linvatec, Corp., Largo, FL, by letters on August 9, 2007. Firm initiated recall is ongoing.
REASON: Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.

PRODUCT: CES Ultra, Cranial Electrotherapy Stimulator, Recall # Z-0712-2008
MANUFACTURER: Recalling Firm: Neuro-Fitness LLC, Fall City, WA, by letter on October 29, 2007. Manufacturer: Arco Electronics Limited, Hong Kong, Hong Kong SAR. Firm initiated recall is ongoing.
REASON: No FDA clearance for the .35Hz/.45Hz frequency option on device.

PRODUCT: Nonin Model 2500 PalmSAT handheld pluse Oximeter, Recall # Z-0843-2008
MANUFACTURER: Nonin Medical, Inc., Plymouth, MN, by letters on October 11, 2007. Firm initiated recall is ongoing.
REASON: Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.

PRODUCT: Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Recall # Z-0916-2008
MANUFACTURER: Ormco Corporation, Glendora, CA, by letters on October 31, 2007. Firm initiated recall is complete.
REASON: Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.

PRODUCT:
a) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Control Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5, Recall # Z-1448-2008;
b) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-002-10, 400 ml-INF. Control Kit w/ 1/8" drain, 3.2 mm, 10Fr, PVC, 107 cm, medium, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Recall # Z-1449-2008;
c) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-003-10; 400 ml INF. Control Kit w/ 3/16" drain, 4.8 mm, 15Fr, PVC, 107 cm, soft, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Recall # Z-1450-2008;
d) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-004-10; 400 ml INF. Control Kit w/ 1/4" drain, 6.4 mm, 19Fr, PVC, 107 cm, large, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Recall # Z-1451-2008;
e) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-050-10; 400 ml Infection Control Comp. Kit, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Recall # Z-1452-2008;
f) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-702-10; 400 ml INF. Control Kit w/ 1/8" Drain Spec., 3.2mm, 10Fr., PVC, 107cm, medium, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Recall # Z-1453-2008;
g) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-703-10; 400 ml INF. Control Kit w/ 3/16" Drain Spec., 4.8mm, 15Fr., PVC, 107cm, soft, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Recall # Z-1454-2008;
h) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF 00-2550-704-10; 400 ml INF. Control Kit w/ 1/4" Drain Spec., 6.4mm., 19Fr., PVC, 107cm, large, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Recall Z-1455-2008;
i) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-002-10, 400 ml evacuators and 450 ml collection bags, 1/8 in. (10 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, medium, contains 10, non-sterile, latex free, Recall # Z-1456-2008;
j) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-003-10; 400 ml evacuators and 450 ml collection bags, 3/16 in. (15 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, soft, contains 10, non-sterile, latex free, Recall # Z-1457-2008;
k) Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number: 47-2550-050-10; 400 ml evacuators and 450 ml collection bags, evaluator tubing and universal Y connectors, adapters for silicone drains, contains 10, non-sterile, latex-free, Recall # Z-1458-2008
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated January 31, 2008. Manufacturer: Zimmer Orthopedic Surgical Products, Dover, OH. Firm initiated recall is ongoing.
REASON: Leakage: The kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use.

CLASS III
PRODUCT: LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), Recall # Z-1317-2008
MANUFACTURER: LifeScan, INC., Milpitas, CA, by letter on December 18, 2007. Firm initiated recall is ongoing.
REASON: Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 9, 2008:

CLASS II
PRODUCT: Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Recall # Z-0617-2008
MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated September 6, 2007. Firm initiated recall is ongoing.
REASON: Brake failure: The brakes may not hold or lock properly.

PRODUCT
a) Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP 150, ASP 145, ASP 180, Recall # Z-0713-2008;
b) Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers: ASP 165, ASP 170, Recall # Z-0714-2008;
c) Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Recall # Z-0715-2008
MANUFACTURER: Recalling Firm: Coloplast Corporation, Minneapolis, MN, by letter on November 12, 2007. Manufacturer: Coloplast Manufacturing France SAS, Sarlat, France. Firm initiated recall is ongoing.
REASON: Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard.

PRODUCT: Stryker ACL Workstation slider, Model Number: 234-010-503, Recall # Z-1107-2008
MANUFACTURER: Stryker Endoscopy, San Jose, CA, by telephone on January 9, 2008 and by letter dated January 10, 2008. Firm initiated recall is ongoing
REASON: Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base.

PRODUCT: Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Recall # Z-1349-2008
MANUFACTURER: AGFA Corporation, Greenville, SC, by telephone and letter on February 22, 2008. Firm initiated recall is ongoing.
REASON: Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also generated on the Nuclear Cardiology Reporting Module.

PRODUCT: Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system, Recall # Z-1383-2008
MANUFACTURER: Nanosphere, Inc., Northbrook, IL, by letters dated February 25, 2008. Firm initiated recall is ongoing.
REASON: Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).

PRODUCT
a) Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC 0641-0392-25 (NDC 0641-0392-21; on vial), Recall Z-1384-2008;
b) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 u/mL-2 mL vial, 25 pack, NDC-0641-0393-25, (NDC-0641-0393-21; on vial), Recall # Z-1385-2008;
c) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25 pack, NDC 0641-2438-45, (NDC 0641-2348-41; on vial), Recall # Z-1386-2008;
d) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 units/mL-30 mL vial; 25pack, NDC 0641-2442-45 (NDC 0641-2442-41; on vial), Recall # Z-1387-2008;
e) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC 0641-0387-25, (NDC 0641-0387-21; on vial), Recall # Z-1388-2008;
f) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack, NDC 0641-0389-25, (NDC 0641-0389-21: on vial), Recall # Z-1389-2008;
g) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC 0641-2436-45, (NDC 0641-2436-41; on vial), Recall # Z-1390-2008;
h) Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-30 mL vial, 25 pack, NDC 0641-2443-45, (NDC 0641-2443-41; on vial), Recall # Z-1391-2008;
i) Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 10units/mL-1 mL vial, 25 pack, NDC 0641-0272-25 (NDC 0641-0272-21: on vial), Recall # Z-1392-2008;
j) Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack, NDC 0641-0273-25 (NDC 0641-0273-21; on vial), Recall # Z-1393-2008
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by Press Release on February 28, 2008, and letters on February 29, 2008, and March 7, 2008. Manufacturer: Baxter Healthcare Corporation, Cherry Hill, NJ. Firm initiated recall is ongoing.
REASON: Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which used the same active pharmaceutical ingredient (API) source as the HEP LOCK products

PRODUCT
a) Mevatron M2/PRIMUS MID Medical Linear Accelerator, Material Number: 019490035, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1394-2008;
b) Mevatron KD2 Medical Linear Accelerator, Material Number: 01940753, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1395-2008;
c) Primus Plus Medical Linear Accelerator, Material Number : 4504200, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1396-2008;
d) Oncor Impression Plus Medical Linear Accelerator, Material Number : 5857912, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1397-2008;
e) Oncor Impression Medical Linear Accelerator, Material Number : 5857920, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1398-2008;
f) Oncor Avante-Garde Medical Linear Accelerator, Material Number: 5857920, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1399-2008;
g) Oncor Expression Medical Linear Accelerator, Material Number: 07360717, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1400-2008;
h) Mevatron KD-2 Medical Linear Accelerator, Material Number: 8515520, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1401-2008;
i) Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1402-2008;
j) Primart MX Medical Linear Accelerator, Material Number: 05500371, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1403-2008;
k) MEVATRON M-2 6300 Medical Linear Accelerator, Material Number: 09401316 with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1404-2008;
l) Mevatron MD2 Medical Linear Accelerator, Material Number: 09401654, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall #Z-1405-2008;
m) Mevatron KDS-2 Medical Linear Accelerator, Material Number: 09411588, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1406-2008;
n) Mevatron KDS-2 Medical Linear Accelerator, Material Number: 09822685, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Recall # Z-1407-2008
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letters dated February 14, 2008. Firm initiated recall is ongoing.
REASON: Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.

CLASS III
PRODUCT: BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, Recall # Z-1366-2008
MANUFACTURER: Biomet 3i, Inc., Palm Beach, FL, by telephone and letter dated February 25, 2008. Firm initiated recall is ongoing.
REASON: Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant. The THA53 is used with an external hex platform).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 2, 2008:

CLASS II
****CORRECTION****
Enforcement Report for March 26, 2008, 08-13, Recall # Z-1367-2008, Gambro,
CODE: All numbers beginning with 6 deleted. Code numbers should now be 003409-400, 003409-410, 003410-500, 003410-510, 003410-710, 003411-500, 003412-500, 003414-500, 003414-510, 003415-510, 003422-500, 003422-515, 003422-520, 003429-500 VOLUME OF PRODUCT IN COMMERCE: 41,000,000 units.

PRODUCT: Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Recall # Z-1050-2008 Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036,
MANUFACTURER: Physio Control, Inc., Redmond, WA, by telephone and letters. Firm initiated recall is ongoing.
REASON: Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA)

PRODUCT:
a) Cardiovascular Procedure Kit, P/N: 70932-01, X-coated Pump and Table Pack, - (the X-coated pump and table pack contains a weighted flexible sucker, Catalog No.: 804113), Recall # Z-1310-2008;
b) Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, (the Pump & table pack contains a weighted flexible sucker, Catalog No. 804113), Recall # Z-1311-2008;
c) Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump &
Table Pack, (Pump & table pack contains a weighted flexible sucker, Catalog No. 804113), Recall # Z-1312-2008;
d) Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump &Table Pack, (the Pump & Table pack contains a weighted flexible sucker, Catalog No. 804113), Recall # Z-1313-2008
MANUFACTURER: Recalling Firm: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated January 29, 2008. Manufacturer: Terumo Cardiovascular Systems Corp., Ashland, MA. Firm initiated recall is ongoing.
REASON: Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.

PRODUCT: Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, Recall # Z-1352-2008
MANUFACTURER: Biosite Inc., San Diego, CA, by letters on December 4, 2007 and December 14, 2007. Firm initiated recall is ongoing.
REASON: False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.

PRODUCT
a) Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450,
A7516-625, HA916-302 and HA916-492, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Recall # Z-1353-2008;
b) Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Recall # Z-1354-2008;
c) Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Recall # Z-1355-2008;
d) Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Recall # Z-1356-2008;
e) Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Recall # Z-1357-2008;
f) Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120, 7-A7516-R1-500 and 8-A7516-R1-120, In vitro diagnostic, 50 mL, 120 mL , 2 L and 500 mL containers, , Recall # Z-1358-2008;
g) Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL containers, Recall # Z-1359-2008;
h) Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Recall # Z-1360-2008
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated February 7, 2008. Firm initiated recall is ongoing.
REASON: Product may be contaminated with microorganisms.

PRODUCT
a) Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing; The device is a preparatory instrument used for femoral knee insertion, Recall # 1361-2008;
b) Biomet Vanguard Knee Instrumentation, Part Number: 32-487062, 67.5/70/75mm Sizing Wing, Biomet UK Ltd, Made in Britain; The device is a preparatory instrument used for femoral knee insertion. (Distributed to Puerto Rico), Recall # Z-1362-2008.
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated February 12, 2008. Firm initiated recall is ongoing.
REASON: The instrument’s sizing line is in the wrong place.

CLASS III
PRODUCT
a) Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Recall # Z-1350-2008;
b) Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Recall # Z-1351-2008
MANUFACTURER: Wescor, Inc., Logan, UT, by letter on January 11, 2008. Firm initiated recall is complete.
REASON: Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing.

PRODUCT
a) BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, Recall # Z-1363-2008;
b) BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA003, 3.0mm, Recall # Z-1364-2008
MANUFACTURER: Biomet 3i, Inc., Palm Beach Gardens, FL, by telephone and letter dated February 15, 2008. Firm initiated recall is ongoing.
REASON: Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa.

PRODUCT: BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X Omm(P) X 2mm(H), Recall # Z-1365-2008
MANUFACTURER: Biomet 3i, Inc., Palm Beach Gardens, FL, by telephone and letter. Firm initiated recall is ongoing.
REASON: The Micro-miniplant Straight Healing Abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of Recalls as of March 26, 2008

CLASS I
MANUFACTURER: Medtronic Neuromodulation, Minneapolis, MN, by letter in January 2008. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories, Recall # Z-1142-2008;
b) Medtronic SynchroMed EL Implantable Infusion Pump, model 8626-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. Recall Z-1143-2008;
c) Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve and suture loops. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. Recall Z-1144-2008;
d) Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve and suture loops. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories, Recall Z-1145-2008;
e) Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve and screened side catheter access port. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories, Recall Z-1146-2008;
f) Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve and screened side catheter access port. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories, Recall Z-1147-2008;
g) Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve, screened side catheter access port and suture loops. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories, Recall Z-1148-2008;
h) Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve, screened side catheter access port and suture loops. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories, Recall Z-1149-2008;
i) Medtronic SynchroMed II Programmable Pump, model 8637-20. The contents of the inner package have been sterilized by ethylene oxide gas. 20 mL reservoir. The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories, Recall Z-1150-2008;
j) Medtronic SynchroMed II Programmable Pump, model 8637-40. The contents of the inner package have been sterilized by ethylene oxide gas. 40 mL reservoir. The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories, Recall Z-1151-2008;
k) Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-20. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 20 mL. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is part of the IsoMed Constant-Flow Infusion System designed to contain and administer parenteral drugs to a specific site. The components of the IsoMed Constant-Flow Infusion System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are implantable devices that store and dispense drugs according to a constant flow rate set during the manufacturing process, Recall Z-1152-2008;
l) Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-35. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 35 mL. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is part of the IsoMed Constant-Flow Infusion System designed to contain and administer parenteral drugs to a specific site. The components of the IsoMed Constant-Flow Infusion System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are implantable devices that store and dispense drugs according to a constant flow rate set during the manufacturing process, Recall Z-1153-2008;
m) Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-60. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 60 mL. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is part of the IsoMed Constant-Flow Infusion System designed to contain and administer parenteral drugs to a specific site. The components of the IsoMed Constant-Flow Infusion System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are implantable devices that store and dispense drugs according to a constant flow rate set during the manufacturing process, Recall Z-1154-2008
REASON: (UPDATED 03/27/08) Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device, describing the problem, patient risks, patient management, recommendations and next steps.

CLASS II
MANUFACTURER: Recalling Firm: AMS Innovative Center - San Jose, CA, by letters, dated April 17, 2007. Manufacturer: American Medical Systems, Minnetonka, MN. Firm initiated recall is ongoing.
PRODUCT: GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and 0010-0075 (international units), Recall #Z-0130-2008
REASON: Component missing: Some products were issued without thermal protection switches.

MANUFACTURER: Recalling Firm: Ventana Medical Systems Inc., Tucson, AZ, by telephone beginning in June 20007 and by letter dated August 17, 2007.
Manufacturer: Bd Diagnostic Systems Tripath, Durham, NC. Firm initiated recall is complete.
PRODUCT: Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Recall # Z-0571-2008
REASON: Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software upgrade adds the algorithm (Slidetype) for the PATHWAY anti-HER-2/neu (4B5) antibody to the VIAS system.

MANUFACTURER: Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter on August 21 and August 23, 2007. Manufacturer: Smith & Nephew, Inc., Endoscopy Division, Mansfield, MA. Firm initiated recall is ongoing.
PRODUCT
a) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligament Screw, Recall # Z-0593-2008
b) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 25 mm, P/N 7211110, Ligament Screw, Recall # Z-0594-2008;
c) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 6 mm x 25 mm, P/N 7211111, Ligament Screw, Recall # Z-0595-2008;
d) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 20 mm, P/N 7211112, Ligament Screw, Recall # Z-0596-2008
e) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligament Screw, Recall # Z-0597-2008;
f) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 7 mm x 25 mm, P/N 7211114, Ligament Screw, Recall # Z-0598-2008
g) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 30 mm, P/N 7211115, Ligament Screw, Recall # Z-0599-2008;
h) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 25 mm, P/N 7211116, Ligament Screw, Recall # Z-0600-2008;
i) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 30 mm, P/N 7211117, Ligament Screw, Recall # Z-0601-2008;
j) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm, P/N 7211118, Ligament Screw, Recall # Z-0602-2008;
k) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 25 mm, P/N 7211119, Ligament Screw, Recall # Z-0603-2008;
l) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 30 mm, P/N 7211120, Ligament Screw, Recall # Z-0604-2008;
m) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 35 mm, P/N 7211121, Ligament Screw, Recall # Z-0605-2008;
n) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 25 mm, P/N 7211122, Ligament Screw, Recall # Z-0606-2008;
o) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 30 mm, P/N 7211123, Ligament Screw, Recall # Z-0607-2008;
p) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm, P/N 7211124, Ligament Screw, Recall # Z-0608-2008;
q) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 30 mm, P/N 7211125, Ligament Screw, Recall # Z-0609-2008;
r) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 35 mm, P/N 7211126, Ligament Screw, Recall # Z-0610-2008;
s) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 12 mm x 35 mm, P/N 7211127, Ligament Screw, Recall # Z-0611-2008;
t) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 20 mm, P/N 72201069, Ligament Screw, Recall # Z-0612-2008;
u) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 20 mm, P/N 72201070, Ligament Screw, Recall # Z-0613-2008;
v) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 20 mm, P/N 72201071, Ligament Screw, Recall # Z-0614-2008;
w) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 25 mm, P/N 72201072, Ligament Screw, Recall # Z-0615-2008;
x) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 8 mm x 25 mm, P/N 72201073, Ligament Screw, Recall # Z-0616-2008
REASON: Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.

MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated October 19, 2007. Manufacturer: Zimmer Manufacturing B.V., Mercedita, PR. Firm initiated recall is complete.
PRODUCT: Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Recall # Z-0620-2008
REASON: Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.

MANUFACTURER: Styker Howmedica Osteonics Corp., Mahwah, NJ, by letters on October 26, 2007, November 2, 2007 and November 6, 2007. Firm initiated recall is ongoing.
PRODUCT
1) Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip Prosthesis Component, Recall # Z-0621-2008;
2) Stryker Orthopaedics UHR Universal Bipolar Component; 26 x 44 mm, Hip Prosthesis Component, Recall # Z-0622-2008;
3) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip Prosthesis Component, Recall # Z-0623-2008;
4) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 45 mm, Hip Prosthesis Component, Recall # Z-0624-2008;
5) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 45 mm, Hip Prosthesis Component, Recall # Z-0625-2008;
6) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 46 mm, Hip Prosthesis Component, Recall # Z-0626-2008;
7) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 46 mm, Hip Prosthesis Component, Recall # Z-0627-2008;
8) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 43 mm, Hip Prosthesis Component, Recall # Z-0628-2008;
9) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 47 mm, Hip Prosthesis Component, Recall # Z-0629-2008;
10) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 47 mm, Hip Prosthesis Component, Recall # Z-0630-2008;
11) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 48 mm, Hip Prosthesis Component, Recall # Z-0631-2008;
12) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 48 mm, Hip Prosthesis Component, Recall # Z-0632-2008;
13) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 49 mm, Hip Prosthesis Component, Recall # Z-0633-2008;
14) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 49 mm, Hip Prosthesis Component, Recall # Z-0634-2008;
15) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 50 mm, Hip Prosthesis Component, Recall # Z-0635-2008;
16) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 50 mm, Hip Prosthesis Component, Recall # Z-0636-2008;
17) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 51 mm, Hip Prosthesis Component, Recall # Z-0637-2008;
18) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 51 mm, Hip Prosthesis Component, Recall # Z-0638-2008;
19) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 52 mm, Hip Prosthesis Component, Recall # Z-0639-2008;
20) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 53 mm, Hip Prosthesis Component, Recall # Z-0640-2008;
21) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 52 mm, Hip Prosthesis Component, Recall # Z-0641-2008;
22) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 53 mm, Hip Prosthesis Component, Recall # Z-0642-2008;
23) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 54 mm, Hip Prosthesis Component, Recall # Z-0643-2008;
24) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 55 mm, Hip Prosthesis Component, Recall # Z-0644-2008;
25) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 55 mm, Hip Prosthesis Component, Recall # Z-0645-2008;
26) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip Prosthesis Component, Recall # Z-0646-2008;
27) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 41 mm, Hip Prosthesis Component, Recall # Z-0647-2008;
28) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Component, Recall # Z-0648-2008;
29) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip Prosthesis Component, Recall # Z-0649-2008;
30) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 56 mm, Hip Prosthesis Component, Recall # Z-0650-2008;
31) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 58 mm, Hip Prosthesis Component, Recall # Z-0651-2008;
32) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 61 mm, Hip Prosthesis Component, Recall # Z-0652-2008;
33) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 61 mm, Hip Prosthesis Component, Recall # Z-0653-2008;
34) Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 68 mm, Hip Prosthesis Component, Recall # Z-0654-2008;
35) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 68 mm, Hip Prosthesis Component, Recall # Z-0655-2008;
36) Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 72 mm, Hip Prosthesis Component, Recall # Z-0656-2008
REASON: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by an Update Instruction package in December 2007. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
PRODUCT:
a) Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Recall # Z-1042-2008;
b) Siemens Magnetom Harmony syngo. Model Number: 7106714, Recall # Z-1043-2008;
c) Siemens Magnetom Harmony sygno. Model Number: 7104693, Recall # Z-1044-2008;
d) Siemens Magentom Symphony, Model Number: 4760265, Recall # Z-1045-2008;
e) Siemens Magnetom Sonata syngo, Model Number: 7106425, Recall # Z-1046-2008;
f) Siemens Magnetom Symphony syngo, Model Number: 7104594, Recall # Z-1047-2008;
g) Siemens Magentom Symphony syngo Upgrade, Model Number: 7106557, Recall # Z-1048-2008;
h) Siemens Magnetom Sonata syngo, Model Number: 7104719, Recall # Z-1049-2008
REASON: Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room.

MANUFACTURER: Draeger Medical, Inc., Telford, PA, by letter on February 1, 2008. Firm initiated recall is ongoing.
PRODUCT:
a) Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505, Recall # Z-1051-2008;
b) Draeger GT500. Globe Trotter Transport System. Catalog Number: MU20508, Recall # Z-1052-2008;
c) Draeger Globe Trotter IC, Catalog Number: MU20509, Recall # Z-1053-2008
REASON: Heating failure - The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.

MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on July 19, 2007. Manufacturer: Nypro, Gurnee, IL. Firm initiated recall is complete.
PRODUCT: UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Recall # Z-1108-2008
REASON: Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result.

MANUFACTURER: Abbott Laboratories, Inc., South Pasadena, CA, by letter on October 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Abbott Clinical Chemistry Creatine Kinase, Model LN 7D63-30, Expires October 19, 2007, RCR#2018433-10/25/07-006R, Recall # Z-1109-2008

REASON: Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An Increased imprecision, or (3) Error Code 1054 (Unable to calculate results, Reaction Failure) on Architect cSystems.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on January 28, 2008. Manufacturer: Stryker Leibinger Gmbh, Freiburg, Germany. Firm initiated recall is ongoing.
PRODUCT: Stryker Orthopedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile, Titanium Alloy, Recall # Z-1297-2008
REASON: Screws do not have locking threads.

MANUFACTURER: Gambro Dasco S.p.A. Monitor Division, Medolla, Italy, by letter on September 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Gambro cartridge blood set with Phoenix Hemodialysis System, Recall # Z-1367-2008
REASON: Tube kinking - Improper tubing installation may result in serious injury or death.

CLASS III
MANUFACTURER: Parks Medical Electronics Inc., Aloha, OR, by email on September 28, 2007 and November 8, 2007, by telephone on October 1, 2007 and by letters on November 28, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes), Recall # Z-0670-2008;
b) Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes), Recall # Z-0671-2008;
c) Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without accompanying probes), Recall # Z-0672-2008;
d) Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL (finished assembly without accompanying probes), Recall # Z-0673-2008
REASON: Premature battery failure: Wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter.

MANUFACTURER: Civco Medical Instruments Inc., Kalona, IA, on January 16, 2008. Firm initiated recall is complete.
PRODUCT : CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #677-057, packaged 1 needle guide per tyvek pouch, 20 pouches per box, Recall # Z-1054-2008
REASON: Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide (p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054).

MANUFACTURER: LifeCell Corporation, Somerville, NJ, by telephone, and letter on October 17, 2007. Firm initiated recall is ongoing.
PRODUCT
a) AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, Recall # Z-1298-2008;
b) AlloCraft DBM with Syringe Assembly, 10 CC, Recall # Z-1299-2008
REASON: Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reactive for both Hepatitis B Surface Antigen and Hepatitis B Core IgM/IgG Antibody)

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of Recalls as of March 19, 2008

CLASS II
***CORRECTION***
Reference FDA Enforcement Report 08-11, March 12, 2008, Recall Z-0576-2008, Roche COBAS 6000 Clinical Chemistry analyzer. For the Distribution of this recall, the code listed as NB should be NE (Nebraska).
MANUFACTURER: Allez Spine, LLC, Irvine, CA, by email on July 30, 2007 and February 29, 2008. Firm initiated recall is complete.
PRODUCT
a) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 35, Catalog Number LG-PR0835, Recall # Z-0186-2008;
b) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 40, Catalog Number LG-PR0840, Recall # Z-0187-2008;
c) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845, Recall # Z-0188-2008;
d) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 50, Catalog Number LG-PR0850, Recall # Z-0189-2008;
e) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 55, Catalog Number LG-PR0855, Recall # Z-0190-2008;
f) Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Recall # Z-0191-2008
REASON: Screw Shank Failure; separation of the screw shank portion from the pedicle head portion of the Size 8 Pedicle Screw, when torquing down the single piece locking nut during implantation.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letter on October 27, 2006. Firm initiated recall is ongoing.
PRODUCT: Abbott - CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators and CELL-DYN 16 Controls. Part/Model Number: 07H77-01, Recall # Z-0455-2008
REASON: Incorrect Results: Hemoglobin results in donor samples assayed on the CELL-DYN 1800 System vary more than expected across the range of claimed operating temperatures of 18 degrees Celcius to 30 degrees Celcius.

MANUFACTURER Biomet, Inc., Warsaw, IN, by letter dated October 18, 2007. Firm initiated recall is complete.
PRODUCT
a) Biomet RINGLOC + Instrumentation Impactor Plate, Size 20; REF/Part #: 31-400620, Recall # Z-0700-2008;
b) Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF/Part #: 31-400621, Recall # Z-0701-2008;
c) Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part #: 31-400622, Recall # Z-0702-2008;
d) Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Recall # Z-0703-2008;
e) Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Recall # Z-0704-2008;
f) Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Recall # Z-0705-2008
REASON: The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letters on or about September 6, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, Recall # Z-0716-2008;
b) GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, Recall # Z-0717-2008
REASON: Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator.

MANUFACTURER: Bayer Healthcare LLC, Mishawaka, IN, by press release and letter on December 21, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclosed; Products 1802 and 1802N (U.S.), 1810 (Korea), 1811 (India, Korea and Mexico) and 1825 (Mexico), Recall # Z-0931-2008;
b) Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea); 1832, 1833 and 1837 (India); 1823 and 1825 (Mexico), Recall # Z-0932-2008
REASON: Inaccurate Test Strips Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.

MANUFACTURER: Recalling Firm: Sound Surgical Technologies, LLC, Louisville, CO, by letter on December 28, 2007. Manufacturer: Linemaster Switch Corporation, Woodstock, CT. Firm initiated recall is ongoing.
PRODUCT: Linemaster Wireless Footswitch Accessory, Model SP-9970214-005112010 and Model SP-9970214-005112232, Recall # Z-0933-2008
REASON: Failure to shut-off: Surgical equipment, activated by a wireless foot switch with VASER system, may remain powered on when switch is no longer depressed.

MANUFACTURER: Stryker Instruments Division of Stryker Corporation, Portage, MI, by letter dated February 13, 2008. Firm initiated recall is ongoing.
PRODUCT:
a) Stryker VertePort, 10 G Access Cannula w/Long Stylet System, REF 306-400, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Recall # Z-1192-2008;
b) Stryker VertePort, 10 G Cement Cannula, REF 306-410, Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Recall # Z-1193-2008
c) Stryker VertePort, 10 G Access Canula (short), REF 306-430, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Recall # Z-1194-2008;
d) Stryker VertePort , 11 G Cement Cannula, REF 306-510 , Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Recall # Z-1195-2008
REASON: Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy).

MANUFACTURER: Recalling Firm: Smith and Nephew, Inc., Wound Management Division, Largo, FL, by letter dated November 21, 2007. Manufacturer: Winer Industries (Shenzhen) Co., Ltd., Shenzhen, China. Firm initiated recall is ongoing.
PRODUCT:
a) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LV1, Exu-Dry Large Burn Vest, Recall # Z-1199-2008;
b) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LJ1, Exu-Dry Large Burn Jacket, Recall # Z-1200-2008;
c) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LPL, Exu-Dry Leg Dressing, Recall # Z-1201-2008;
d) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L72, Exu-Dry Sheet 36"x72" Non-Permeable, Recall # Z-1202-2008;
e) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L73, Exu-Dry Sheet 36"x72" Non-Permeable with Straps, Recall # Z-1203-2008;
f) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L74, Exu-Dry Sheet 36"x72" Permeable with Straps Quilted, Recall # Z-1204-2008;
g) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999MJ1, Exu-Dry Medium Burn Jacket, Recall # Z-1205-2008;
h) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M36, Exu-Dry Pad 24"x36" Non-Permeable Heavy Absorbency, Recall # Z-1206-2008;
i) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999BP1, Exu-Dry Adult Buttocks Dressing, Recall # Z-1207-2008;
j) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999028, Exu-Dry Dressing, 20" x 28", Recall # Z-1208-2008;
k) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999018, Exu-Dry Dressing, 15" x 18", Recall # Z-1209-2008;
l) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999024, Exu-Dry Dressing, 15" x 24", Recall # Z-1210-2008;
m) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M09, Exu-Dry Dressing, 15" x 9", Recall # Z-1211-2008;
n) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M18, Exu-Dry Dressing, 15" x 18", Recall # Z-1212-2008;
o) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M24, Exu-Dry Dressing, 15" x 24", Recall # Z-1213-2008;
p) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M28, Exu-Dry Dressing, 15" x 28", Recall Z-1214-2008;
q) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M37, Exu-Dry Pad 24"x36" Non-Permeable Medium Absorbency, Recall Z-1215-2008;
r) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M38, Exu-Dry Pad 24"x36" , Permeable Medium Absorbency, Recall # Z-1216-2008;
s) Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999SJ1, Exu-Dry Small Burn Jacket, Recall # Z-1217-2008
REASON: Sterility (package integrity) compromised: Distribution of product that did not meet specifications, open seals.

CLASS III
MANUFACTURER: Exactech, Inc. Gainesville, FL, letter on October 31, 2007. Firm initiated recall is ongoing.
PRODUCT: Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Recall # Z-0572-2008
REASON: Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of Recalls as of March 12, 2008

CLASS II
MANUFACTURER: BD Biosciences, San Jose, CA, by letter on September 14, 2007. Firm initiated recall is ongoing.
PRODUCT: BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, Recall # Z-0570-2008
REASON: Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.

MANUFACTURER: Recalling Firm: Stryker Endoscopy, San Jose, CA, by telephone and letter dated November 19, 2007. Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Recall # Z-0573-2008;
b) Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical Suction Tip, Recall # Z-0574-2008
REASON: Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone and follow-up letter dated December 4, 2007. Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.
PRODUCT: Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Recall # Z-0576-2008
REASON: Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by Urgent Medical Device Notification on September 18, 2007. Firm Initiated recall is ongoing.
PRODUCT: Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Recall # Z-0719-2008
REASON: Software error: Error affects all Aspen customer systems using the PAL video standard configuration and has a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips stored from within any Perspective advanced display option (specifically: 3D Surface Rendering, 3D MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reconstruction or FreeStyle extended imaging, FreeStyle compounding, or FreeStyle dynamic CDI technology).

MANUFACTURER: Zimmer Orthopaedic Surgical Products, Dover, OH, by letter dated January 8, 2008. Firm initiated recall is ongoing.
PRODUCT:
a) Pulavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-420-00, 10 kits/package, Recall # Z-0856-2008;
b) Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package, Recall # Z-0857-2008;
c) Pulsavac Plus Wound Debridement System, Fan Spray Kit , Catalog #00-5150-475-00, 10 kits/package, Recall # Z-0858-2008;
d) Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/package, Recall # Z-0859-2008;
e) Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package, Recall # Z-0860-2008;
f) Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10
kits/package, Recall # Z-0861-2008;
g) Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package, Recall # Z-0862-2008;h) Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package, Recall # Z-0863-2008;
i) Pulsavac Plus Wound Debridement System, Shower Spray Kit, Catalog #00-5150-495-00, 10kits/package, Recall # Z-0864-2008;
j) Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/package, Recall # Z-0865-2008
REASON: Sterility (package integrity) compromised: The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.

MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated November 20, 2007. Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
PRODUCT:
a) Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R, Made in U.S.A, Recall # Z-0946-2008
b) HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R, Recall # Z-0947-2008
REASON: Unrecorded Infusion: If the system is powered down or a power failure occurs during a fill cycle, the HomeChoice system may not record the last 1-4 pump strokes infused into the patient when the power is restored. This situation may create a potential unrecorded delivery of approximately 15-60 mL of fluid being infused into the patient.

MANUFACTURER: Custom Ultrasonics, Inc., Ivyland, PA, by letter dated February 11, 2008. Firm initiated recall is ongoing.
PRODUCT: System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Recall # Z-1182-2008
REASON: Inadvertent selection of the “wash” cycle.

MANUFACTURER: Recalling Firm: Chattem Inc., Chattanooga, TN, by press release on February 8, 2008 and by letter on February 12, 2008. Manufacturer: Mycoal Products Corp., Tochigi-City, Japan. Firm initiated recall is ongoing.
PRODUCT:
a) Icy Hot Heat Therapy, Air Activated Heat Patch, Back and Large Areas, UPC Code 0-41167-08330-7, Product Code 08330, 4.1" x 8.4" (10.5 cm x 2.1 cm) each, 1 and 3 count patches, Recall # Z-1196-2008;
b) Icy Hot Heat Therapy, Air Activated Heat Patch, Arm, Neck and Leg and Small Areas, UPC Code 0-41167-08335-2, Product Code 08335, 3.9" x 5.3" (10cm x 13.5 cm) each, 1 and 4 count patches, Recall # Z-1197-2008;
c) Aspercreme, Pain Relieveing Creme with Aloe, Maximum Strength Formula, Net Wt 3 oz (85g) with Bonus Icy Hot Heat Therapy Air Activated Heat Patch, 1 individually wrapped patch, 3.9" x 5.3" (10cm x 13.5cm), Recall # Z-1198-2008
REASON: Skin irritation and burns with product usage.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of Recalls as of March 5, 2008

CLASS II
MANUFACTURER: AMS Innovative Center - San Jose, San Jose, CA, by letters. Firm initiated recall is ongoing.
PRODUCT: American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia), Recall # Z-0131-2008
REASON: Control knob break: The knob used to finely control the direction of the laser energy may break.

MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by visit between August 14 and 31, 2007. Firm initiated recall is ongoing.
PRODUCT: Smiths Medical CADD-Sentry Pro Medication Safety Software – electronic pump protocol programming software – Administrator REF 21-6275-51 RX only, Recall # Z-0134-2008
REASON: Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if Administrator displayed the values correctly at data entry.

MANUFACTURER: Tenet Medical Engineering, Inc., Calgary, Canada, by letter on November 23, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) # 7691; Sterile, Recall # Z-0577-2008;
b) TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) # 7692; Sterile, Recall # Z-0578-2008;
c) TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) # 7693;
Sterile, Recall # Z-0579-2008
REASON: Sterility compromised: Sterility seals on some of the firm’s wrist stabilization kit pouches may be compromised.

MANUFACTURER: Orthofix, Inc., Mckinney, TX, by telephone starting on September 28, 2007. Firm initiated recall is ongoing.
PRODUCT: Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, 150mm; Catalog Number: 50-1015, Recall # Z-0674-2008
REASON: Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.

MANUFACTURER: Recalling Firm: Stryker Orthopaedi, Mahwah, NJ, by letters on November 26, 2007. Manufacturer: Stryker Orthopaedi, Limerick, Ireland. Firm initiated recall is ongoing.
PRODUCT:
a) Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem 10x102; Catalog Number: 6485-3-300; Recall # Z-0917-2008;
b) Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 8x102; Catalog Number 6485-3-308; Recall # Z-0918-2008;
c) Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 9 x 102; Catalog Number: 6485-3-309; Recall # Z-0919-2008;
d) Stryker Modular Replacement System Curved Cemented Stem; MRS 11mmx203mm femoral stem. Catalog Number: 6485-3-311; Recall # Z-0920-2008;
e) Stryker Modular Replacement System Curved Cemented Stem; MRS 12mmx203 Femoral Stem; Catalog Number: 6485-3-313; Recall Z-0921-2008;
f) Stryker Modular Replacement System Curved Cemented Stem; MRS 15mmx203mm Femoral Stem; Catalog Number: 6485-3-315; Recall # Z-0922-2008;
g) Stryker Modular Replacement System Curved Cemented Stem; MRS 17mmx203 Femoral Stem; Catalog Number 6485-3-317; Recall # Z-0923-2008;
h) Stryker Modular Replacement System Curved Cemented Stem; MRS 11x127 Curved Femoral Stem; Catalog Number: 6485-3-711; Recall # Z-0924-2008;
i) Stryker Modular Replacement System Curved Cemented Stem; MRS 13x127 Curved Femoral Stem; Catalog Number: 6485-3-713; Recall # Z-0925-2008;
j) Stryker Modular Replacement System Curved Cemented Stem; MRS 15x127 Curved Femoral Stem; Catalog Number: 6485-3-715; Recall # Z-0926-2008;
k) Stryker Modular Replacement System Curved Cemented Stem; MRS 17x127 Curved Femoral Stem; Catalog Number: 6485-3-717; Recall # Z-0927-2008
REASON: Curvature Discrepancy: The radius of curvature may be out of specification to varying degrees causing a discrepancy in the stem curvature between trials and implants.

MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta, PR, by letters on October 26, 2007.Firm initiated recall is ongoing.
PRODUCT:
a) Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution; List # 9512-60, Recall # Z-0928-2008;
b) Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution; List # 9512-85, Recall # Recall # Z-0929-2008;
c) Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle of gentamicin flourescein tracer; List # 7A65-20;Recall # Z-0930-2008
REASON: Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F span with these reagents lots, which may produce the following results: Printed Error Code "SPAN LESS THAN MIN SPAN" - Controls out of range. When a control is out of range, patient results should not be reported.

MANUFACTURER: Advanced Bionics Corp., Sylmar CA, by letter on October 5, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Recall # Z-0960-2008;
b) Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1100 with firmware version prior to Revision 3.02, Recall # Z-0961-2008
REASON: Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of "10h0" or "00h0" through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informational purposes. ** It should be noted that there is no effect to the actual functionality of the IPG.**

MANUFACTURER: Recalling Firm: Arjo, Inc. Roselle, IL, by letters dated December 19, 2007. Manufacturer: B.H.M. Medical, Inc., Magog, Canada. Firm initiated recall is ongoing.
PRODUCT
a) BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510. These scales were sold for installation on or as a component of the following patient lifts: a): Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift; Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift;
Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift;
b) Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale; Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale, Model HPL-600WBSC; Part Number: 9600132.06, Hoyer-600 Wide Opening Patient Lifter with Scale, Recall # Z-1135-2008;
b) BHM Medical Scales, 1000 lb. scales weight limit; Part Number 700.00525; These scales were sold for installation on the Model V10 and Model Maxisky fixed ceiling lifts. Part 700.00525, Recall # Z-1136-2008
REASON: Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of February 27, 2008

CLASS II
MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by letter and software upgrade beginning on March 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Model Number: IS 2000, Software Revision Numbers: A5.0 P5 and A5.1 P1, Recall # Z-0079-2008
REASON: System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe "soft-lock" state.

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by letter on October 4, 2007 and e-mail on October 5, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS1200 with Isolation Transformer (P/N: 952012) and Vision Cart (Model VS1000), Recall # Z-0151-2008;
b) Intuitive brand da Vinci S Surgical System, Endoscopic Instrument Control System, Model IS2000 with Isolation Transformer (P/N: 952012) and Vision Cart (Model: VS2000), Recall # Z-0152-2008
REASON: Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use of an under-rated fuse will result in failure of the fuse and a loss of power to the vision cart, including the loss of power to any ancillary equipment that may be connected to the vision cart isolation transformer.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated November 21, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Hill-Rom Affinity Birthing Bed, Model P3600, Recall # Z-0581-2008;
b) Hill-Rom Affinity Birthing Bed, Model P3600, Recall # Z-0582-2008;
c) Hill-Rom Affinity Birthing Bed, Model P3700A, Recall # # Z-0583-2008;
d) Hill-Rom Affinity Birthing Bed, Model P3700B. Note: Not distributed in the U.S.,
Recall # Z-0584-2008
REASON: Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated.

MANUFACTURER: Nova Biomedical Corporation, Waltham, MA, by letter dated November 19, 2007. Firm initiated recall is complete.
PRODUCT:
a) Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Recall # Z-0724-2008;
b) Nova - EZ CHEM Control Solution P/N 9612, Recall # Z-0725-2008;
c) Nova - EZ CHEM Linearity Solution P/N 9618, Recall # Z-0726-2008
REASON: Incorrect Results – Creatinine results were lower than the laboratory reference method.

MANUFACTURER: Recalling Firm: Carestream Heath Inc., Rochester, NY, by letters on December 21, 2007. Manufacturer: Kodak Electronic Products (Shanghai) Co., Ltd., Shanghai, Pudong, China. Firm initiated recall is complete.
PRODUCT: Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360, 6551386, 6552152, 6552160, 6551345, 6552319, 6552335, Recall # Z-0731-2008;
REASON: Unintended Positioner Movement - The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after a collision has occurred with the Quantum Table.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on November 27, 2007. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
PRODUCT: Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Recall # Z-0732-2008
REASON: Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusually high)

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, July 27, 2007 by visits. Firm initiated recall is ongoing.
PRODUCT:
a) Siemens Primus Linear Accelerator System,
PRIMART MX Linear Accelerator System;
PRIMUS Mid, Part Number: 1940035 and
PRIMART MX, Part Number: 5500371,
Recall # Z-0850-2008;
b) Siemens Mevatron Linear Accelerator Systems:
KD2, K 7767, K 8067, KD, KDS and KDS2,
Mevatron KD2, Part No.: 1940753;
Mevatron KD2, Part No.: 08515520;
Mevatron KD2-Part No.: 9822685;
Mevatron K 7767, Part No.: 5694302;
Mevatron K 8067, Part No.: 5694401;
Mevatron KD, Part No.: 8319857;
Mevatron KDS, Part No.: 9401522;
Mevatron KDS2, Part No.: 9411588; and
Mevatron KDS2, Part No.: 9822693,
Recall # Z-0851-2008;
c) Siemens Mevatron Linear Accelerator Systems;
Mevatron M 7440, Part No.: 5672977;
Mevatron M 6700, Part No.: 5693908;
Mevatron M 6730, Part No.: 5694005;
Mevatron M 7140, Part No.: 5694104;
Mevatron M 7400, Part No.: 5694153;
Mevatron M 7445, Part No.: 5694203;
Mevatron M 6300, Part No.: 8317000;
Mevatron M 6740, Part No.: 8319758;
Mevatron MD, Part No.: 8319808;
Mevatron ME, Part No.: 8490005;
Mevatron MDX, Part No.: 8496200;
Mevatron M2 6300, Part No.: 9401316;
Mevatron M2 6700, Part No.: 9401407;
Mevatron M2 6740, Part No.: 9401506;
Mevatron MD2, Part No.: 09401654; and
Mevatron MDX-2, Part No.: 9401746, Recall # Z-0852-2008
REASON: Door Hinge failures; loose or falling off (Stationary Structure Doors).

CLASS III
MANUFACTURER: Recalling Firm: Invictus Scientific Inc., San Diego, CA, by letter beginning on November 20, 2007. Manufacturer: Bionime Corporatio, Dall City, Taiwan. Firm initiated recall is ongoing.
PRODUCT: Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300, Recall # Z-0728-2008
REASON: Abnormal Memory Recall: When the meter is fixed in 12 hour mode, the time frame display of all memory data will be shown incorrectly as AM or PM depending on when the user is recalling the memory stored in the meter. This will cause confusion as to when the last test was taken.

MANUFACTURER: Tri-State Hospital Supply Corporation, Howell, MI, by letter on October 25, 2007. Firm initiated recall is complete.
PRODUCT:
a) Centurion Healthcare Products Laceration Tray, sterile; The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among other components, however some kits may contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety Needle itself is the correct size. (Reorder SUT8805A), Recall # Z-0729-2008;
b) Centurion Healthcare Products Laceration Tray, sterile; The primary kit is labeled as containing 1 needle, 21G x 1-1/2", among other components, however some kits may contain a 21Gx1" needle. The label on the Kendall Monoject Magellan 21G Safety Needle itself is the correct size. (Reorder SUT8805A), Recall # Z-0730-2008
REASON: Incorrect Needle size: Some of the kits contain a 1 inch 21G needle instead of the 1-1/2 inch 21G needle specified on the kit label.

MANUFACTURER: First Aid Only, Inc., Vancouver, WA, by letter dated October 10, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) First Aid Kits, soft canvas, plastic, and metal containers holding various products to include ibuprofen and other first aid supplies, in various sizes. Kits include:
Labeled with First Aid Only, Inc: Recreational Sports First Aid, Item SM-134;
Welder's First Aid Kit, Item 253-U;
Vehicle First Aid Kit, Item 220-0;
On-The-Road Auto First Aid, Item FAO-310;
Auto First Aid Essentials, Item FAO-340;
Auto First Aid Essentials, Item FDA-532;
Auto First Aid Essentials, Item FDA-552;
Vehicle First Aid Kit, Item 221-U;
Outdoor First Aid Kit, Item FAO-410;
Outdoor First Aid Kit, Item FAO-410
Outdoor First Aid Kit, Item FAO-420;
Outdoor First Aid Kit, Item FAO-430;
Outdoor First Aid Kit, Item FAO-440;
First Aid & Survival Kit, Item FA-462;
First Aid Kit, FAO-422-06;
First Aid Kit, 403-PC;
First Aid Response Kit, FA-504;
All Purpose First Aid Kit, Item FAO-112;
All Purpose First Aid Kit, Item FAO-122;
All Purpose First Aid Kit, Item FAO-142;
All Purpose First Aid Kit, Item FAO-432;
All Purpose First Aid Kit, Item FAO-444;
All Purpose First Aid Kit, Item FAO-452;
First Aid Essentials, Item FAO-130;
First Aid Essentials, Item FAO-132;
First Aid Essentials, Item FAO-134;
First Aid Essentials, Item FAO-422;
First Aid Essentials, Item FAO-428;
First Aid Essentials, Item FAO-432;
First Aid Essentials, Item FAO-442;
Refillable First Aid Kit, FAO-490C;
Refillable First Aid Kit, FAO-490C;
Brite Stock first aid kits; Item FAO-130-BS; Item FAO-132-BS;
Item FAO-134-BS;
Lake & Trail Outdoor First Aid Kit, Item MJR-420;
Lake & Trail Outdoor First Aid Kit, Item MJR440;
First aid kits labeled: meijer First Aid Kit, Item MJR-130;
meijer First Aid Kit, Item MJR-442;
First Aid Kits labeled FIRST AID Exchange:
General Purpose Home First Aid Kit, Item 2800;
Auto First Aid Kit, Item 2825;
First Aid Kit: All purpose First Aid Kit, Item FAO-132-MS First Aid Kit;
Ready Solutions: First Aid Kit, Item 90030;
First Aid Kit labeled NORTHERN Safety Co., Inc.:
First Aid Kit, Item FAO-442-NS;
First Aid Kit: Grafco First Aid Kit, Item 1799-9133
and First Aid Kit labeled -Provided by MOTURIS LTD- Custom Kit,
Item 9099, Recall # Z-0853-2008;
b) First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen tablets and a variety of other first aid supplies: Item 249-0/FAO Item 249-0/P Item 249-RK/P First Aid Exchange brand cabinet: Item 1300-FAE-0103 Item 1300-FAE-0108 and Item 1300-PAT-0109, Recall # Z-0854-2008;
c) Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid Only, Inc., Vancouver, WA. Ibuprofen Tablets, Item A405-WIP, Item A405-10 Ibuprofen Tablets, Item FAE-7014;; Ibuprofen Tablets, Item H430; Ibuprofen Tablets, Item I431; Ibuprofen Tablets, item J432 and Ibuprofen Tablets, item Z6100, Recall # Z-0855-2008
REASON: Failed USP Impurity testing: the Ibuprofen supplied by its own manufacturer, used in these first aid kits, tablet refills, and cabinets, is being recalled for failing its USP limits for impurities during stability testing.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of Recalls as of February 20, 2008

CLASS II
MANUFACTURER: Recalling Firm: Abbott Diabetes Care, Inc., Alameda, CA, by letter, telephone or visit starting August 23, 2007, and by press release and letters dated August 31, 2007. Manufacturer: Benchmark Electronics (Thailand) Public Co., Ltd., Ayudhaya, Thailand. Firm initiated recall is ongoing.
PRODUCT: Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xceed meter, Optium Xceed meter, Optium meter, ReliOn Ultima meter, Rite Aid meter, Kroger meter, Omron HEA-214 meter, Optium Xido meter, Boots meter, Recall # Z-0112-2008
REASON: Damage could lead to no display. Meters manufactured after January 31, 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and date/time fields, in addition to complete blanking of the numerical reading portion of the display.

MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by letter on September 10, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC, -- 6MV SRS photon beam, -- Fine Beam Isocenter Accuracy, -- Stereotactic motion disable, Recall # Z-0544-2008;
b) Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system; Model: Low Energy Clinacs with one or more of the following options: -- BrainLAB micro MLC, Recall # Z-0545-2008
REASON: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.

MANUFACTURER: Phillips Nuclear Medicine, Milpitas, CA, by letter on September 28, 2007. Firm initiated recall is ongoing.
PRODUCT: Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5, Recall Z-0676-2008
REASON: Incorrect Measurement: The firm discovered a software defect in Cardiac and Pulmonary Viewer software application options used in the Precedence CT Sub-System. The defect causes incorrect measurements in derived images which are zoomed and saved in a batch file.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on August 7, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 08515520, Recall # Z-0677-2008;
b) Siemens Mevatron MD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 09401654, Recall # Z-0678-2008;
c) Siemens Mevatron M-2 6740 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position)Model Number: 9401506, Recall # Z-0679-2008;
d) Siemens Mevatron KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9822693 and 9411588, Recall # Z-0680-2008;
e) Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9822685, Recall # Z-0681-2008;
f)Siemens Mevatron MDX-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model number 9401746, Recall # Z-0682-2008;
g) Seimens Mevatron M-2 6700 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9401407, Recall # Z-0683-2008;
h) Seimens Mevatron M-2 6300 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 9401316, Recall # Z-0684-2008;
i) Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940753, Recall # Z-0685-2008;
j) Siemens Mevatron M-2 PRIMUS mid-energy Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number: 1940035, Recall # Z-0686-2008;
k) Siemens Mevatron M-2 PRIMUS hi-energy Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 4504200, Recall # Z-0687-2008
REASON: Incorrect field size -- Products manufactured prior to 1999 may experience jaw field size errors during interlock resulting in potential mistreatment if a light field check is not performed. This problem is present in machines with serial numbers less than 3094, as they do not contain redundant sensors for jaw position.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated December 3, 2007. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
PRODUCT: Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322, Recall # Z-0688-2008
REASON: False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBAS INTEGRA 400 or COBAS INTEGRA 400+ analyzers.

MANUFACTURER: Recalling Firm: Hamilton Co., Reno, NV, by letter on June 25, 2007. Manufacturer: Hamilto Bonaduz AG, Bonaduz, Switzerland. Firm initiated recall is ongoing.
PRODUCT: Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24). Product Code: 866.2500; Part Number: 173400, Recall # Z-0718-2008
REASON: Mislabeled. Product has the wrong barcode labeling.

MANUFACTURER: Varian Medical Systems Inc, Palo Alto, CA, by letter on October 2, 2007. Firm initiated recall is ongoing.
PRODUCT: Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models, Recall # Z-0720-2008
REASON: Incorrect Software Validation. The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be administered to a patient whereby the gantry will not rotate, resulting in delivery to a single location rather than through the gantry arc.

MANUFACTURER: Advanced Sterilization Products, Irvin, CA, by letters beginning on November 13, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) STERRAD 100S Sterilizer, Product Code: 10101, Recall # Z-0845-2008;
b) STERRAD 50 Sterilizer, Product Code:10050, Recall # Z-0846-2008;
c) STERRAD 200 Sterilizer, Product Code: 10201, Recall # Z-0847-2008;
d) STERRAD NX Sterilizer, Product Code: 10033, Recall # Z-0848-2008
REASON: User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued.

MANUFACTURER: Rockwell Medical Technologies, Inc., Grapevine, TX, by letters, e-mail and fax on December 3, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) RenalPure® Liquid Acid Concentrate R-006; One Gallon (3.78 liters), Recall # Z-0871-2008;
b) RenalPure® Liquid Acid Concentrate R-235; One Gallon (3.78 liters), Recall # Z-0872-2008;
c) RenalPure® Liquid Acid Concentrate R-259; One Gallon (3.78 liters), Recall # Z-0873-2008;
d) Glacial Acidic Acid (liquid component of Dri-Sate® Dry Acid Concentrate DR-215); 1 quart (0.95 liters), Recall # Z-0874-2008;
e) Dri-Sate® Glacial Acidic Acid (liquid component of Dri-Sate® Dry Acid Concentrate DR-240); 1 quart (0.95 liters), Recall # Z-0875-2008
REASON: Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.

MANUFACTURER: Recalling Firm: Smiths Medical MD, Inc., Saint Paul, MN, by letters on December 21, 2007. Manufacturer: Smiths Healthcare Manufacturing S.A. de C.V., Tijuana, B.C., Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 50 ml, Reorder No. 21-7001-24, nonvented stopper included, Sterile, Recall # Z-0876-2008;
b) Smiths CADD Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml., Reorder No. 21-7002-24, Nonvented stopper included, Sterile, Recall # Z-0877-2008;
c) Smiths CADD Yellow Medication Cassette Reservoirs with Clamp and Female Luer, 100 ml, Reorder No.21-7100-24, nonvented stopper included, Sterile, Recall # Z-0878-2008;
d) Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, nonvented stopper included, Sterile, Recall # Z-0879-2008
REASON: Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps.

MANUFACTURER: Recalling Firm: Abbott Spine, Austin, TX, by telephone beginning December 19, 2007. Manufacturer: Gauthier Biomedical, Grafton, WI. Firm initiated recall is ongoing.
PRODUCT: Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Harmony 2900-0002-PL, Cadence 1500-0002-PL and Cadence 1500-0008-PL, Recall # Z-0880-2008
REASON: Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearings during use.

CLASS III
MANUFACTURER: Interpore Cross International Inc., Irvine, CA, by letters on October 26, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002, DBM005, DBM010, DBMW05 & DBMW10, (lnterGro DBM products contain human tissue (allograft bone) and are intended for transplantation), Recall # Z-0618-2008;
b) Allogenix; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: 02-3110, (Allogenix DBM products contain human tissue (allograft bone) and are intended for transplantation), Recall # Z-0619-2008
REASON: Unapproved Testing: Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor tissue instead of the FDA approved screening test. As a result, Interpore Cross International has initiated a recall on specific lots of products containing human tissue from LifeLink.(Note: tissue samples were later re-tested by an approved method and found non-reactive)

MANUFACTURER: Siemens Medical Solutions USA, Inc. Mountain View, CA, by letter on September 18, 2007. Firm initiated recall is ongoing.
PRODUCT: Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Recall # Z-0719-2008
REASON: Software error: Error affects all Aspen customer systems using the PAL video standard configuration and has a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips stored from within any Perspective advanced display option (specifically: 3D Surface Rendering, 3D MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reconstruction or FreeStyle extended imaging, FreeStyle compounding, or FreeStyle dynamic CDI technology).

MANUFACTURER: PML, Inc. dba Pml Microbiologicals Inc., Wilsonville, OR, by telephone on October 15, 2007 and by letter dated October 26, 2007. Firm initiated recall is complete.
PRODUCT:
a) PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901, Catalog # 101364, Recall # Z-0721-2008;
b) PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Catalog # 201130 - Vitek NH ID Card (HHI) Set; Catalog # 101364 - LyfoCults Microorganism, Recall # Z-0722-2008;
c) PML --IDS Rapid NH QC Set- Quality Control kit for culture media, Catalog # 201155. Product label includes LyfoCults IVD - LyfoCults Microorganism, Catalog # 101364, Recall # Z-0723-2008
REASON: Incorrect micro-organism-- .Quality control In-vitro diagnostic test was manufactured with Cryptococcus neoformans (ATCC 76484) instead of Haemophilus parainfluenzae (ATCC 7901).

MANUFACTURER: Recalling Firm: EBI, L.P., Parsippany, NJ, by letters on October 23, 2007. Manufacturer: LifeLink of Georgia, Norcross, GA. Firm initiated recall is ongoing.
PRODUCT: OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm. Catalog Number: 45-5537 and Catalog Number: LGAL906, Recall # Z-0825-2008
REASON: Unapproved Testing: Tissue supplier utilized unapproved diagnostic testing on certain lots of distributed donor tissue instead of the FDA approved donor screening test. (Note: tissue samples were later re-tested by an approved method and found non-reactive).

MANUFACTURER: Popper & Sons, Inc., New Hyde Park, NY, by telephone on/about January 2, 2008 and by letters starting on January 9, 2008. Firm initiated recall is ongoing.
PRODUCT: Perfektum Toomey Evacuating Syringes, REF/Part # 5047, Description: 30CC Lock Tip, Rx only, Non-sterile, Recall # Z-0881-2008
REASON: Mis-labeling. The product name on the label was erroneously declared as Perfectum Toomey Evacuating Syringes instead of Popper Interchangeable Hypodermic Syringes for one lot of the product. Note: the product information (part number, description, lot number) found in the white box portion of the label is listed correctly.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 13, 2008:

CLASS I
MANUFACTURER: Medtronic Neuromodulation, Minneapolis, MN, by letter beginning August 3, 2007. Firm initiated recall is ongoing.
PRODUCT
a) Medtronic SynchroMed EL Programmable Pump, Model 8626-10. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0739-2008;
b) Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0740-2008;
c) Medtronic SynchroMed EL Programmable Pump, Model 8626-18. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0741-2008;
d) Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. (The implantable Medtronic SynchroMed EL Programmable Pump is part to a specific site), Recall # Z-0742-2008;
e) Medtronic SynchroMed EL Programmable Pump, Model 8627-10. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0743-2008;
f) Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0744-2008;
g) Medtronic SynchroMed EL Programmable Pump, Model 8627-18. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site) Recall # Z-0745-2008;
h) Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0746-2008
REASON: Pump motor stall due to gear shaft wear.

MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letter on January 14, 2008. Firm initiated recall is ongoing.
PRODUCT :
1) CORDIS "Dura Star" 2.25 x 10 Dilatation Catheter, Catalog # 70110225, Recall # Z-0747-2008;
2) CORDIS "Dura Star" 2.50 x 10 Dilatation Catheter, Catalog # 70110250, Recall # Z-0748-2008;
3) CORDIS "Dura Star" 2.75 x 10 Dilatation Catheter, Catalog # 70110275, Recall # Z-0749-2008;
4) CORDIS "Dura Star" 3.00 x 10 Dilatation Catheter, Catalog # 70110300, Recall # Z-0750-2008;
5) CORDIS "Dura Star" 3.25 x 10 Dilatation Catheter, Catalog # 70110325, Recall # Z-0751-2008;
6) CORDIS "Dura Star" 3.50 x 10 Dilatation Catheter, Catalog # 70110350, Recall # Z-0752-2008;
7) CORDIS "Dura Star" 3.75 x 10 Dilatation Catheter, Catalog # 70110375, Recall # Z-0753-2008;
8) CORDIS "Dura Star" 4.00 x 10 Dilatation Catheter, Catalog # 70110400, Recall # Z-0754-2008;
9) CORDIS "Dura Star" 2.25 x 15 Dilatation Catheter, Catalog # 70115225, Recall # Z-0755-2008;
10) CORDIS "Dura Star" 2.50 x 15 Dilatation Catheter, Catalog # 70115250, Recall # Z-0756-2008;
11) CORDIS "Dura Star" 2.75 x 15 Dilatation Catheter, Catalog # 70115275, Recall # Z-0757-2008;
12) CORDIS "Dura Star" 3.00 x 15 Dilatation Catheter, Catalog # 70115300, Recall # Z-0758-2008;
13) CORDIS "Dura Star" 3.25 x 15 Dilatation Catheter, Catalog # 70115325, Recall # Z-0759-2008;
14) CORDIS "Dura Star" 3.50 x 15 Dilatation Catheter, Catalog # 70115350, Recall # Z-0760-2008;
15) CORDIS "Dura Star" 3.75 x 15 Dilatation Catheter, Catalog # 70115375, Recall # Z-0761-2008;
16) CORDIS "Dura Star" 4.00 x 15 Dilatation Catheter, Catalog # 70115400, Recall # Z-0762-2008;
17) CORDIS "Dura Star" 2.25 x 20 Dilatation Catheter, Catalog # 70120225, Recall # Z-0763-2008;
18) CORDIS "Dura Star" 2.50 x 20 Dilatation Catheter, Catalog # 70120250, Recall # Z-0764-2008;
19) CORDIS "Dura Star" 2.75 x 20 Dilatation Catheter, Catalog # 70120275, Recall # Z-0765-2008;
20) CORDIS "Dura Star" 3.00 x 20 Dilatation Catheter, Catalog # 70120300, Recall # Z-0766-2008;
21) CORDIS "Dura Star" 3.25 x 20 Dilatation Catheter, Catalog # 70120325, Recall # Z-0767-2008;
22) CORDIS "Dura Star" 3.50 x 20 Dilatation Catheter, Catalog # 70120350, Recall # Z-0768-2008;
23) CORDIS "Dura Star" 3.75 x 20 Dilatation Catheter, Catalog # 70120375, Recall # Z-0769-2008;
24) CORDIS "Dura Star" 4.00 x 20 Dilatation Catheter, Catalog # 70120400, Recall # Z-0770-2008;
25) CORDIS "Dura Star" 2.25 x 25 Dilatation Catheter, Catalog # 70125225, Recall # Z-0771-2008;
26) CORDIS "Dura Star" 2.50 x 25 Dilatation Catheter, Catalog # 70125250, Recall # Z-0772-2008;
27) CORDIS "Dura Star" 2.75 x 25 Dilatation Catheter, Catalog # 70125275, Recall # Z-0773-2008;
28) CORDIS "Dura Star" 3.00 x 25 Dilatation Catheter, Catalog # 70125300, Recall # Z-0774-2008;
29) CORDIS "Dura Star" 3.25 x 25 Dilatation Catheter, Catalog # 70125325, Recall # Z-0775-2008;
30) CORDIS "Dura Star" 3.50 x 25 Dilatation Catheter, Catalog # 70125350, Recall # Z-0776-2008;
31) CORDIS "Dura Star" 3.75 x 25 Dilatation Catheter, Catalog # 70125375, Recall # Z-0777-2008;
32) CORDIS "Dura Star" 4.00 x 25 Dilatation Catheter, Catalog # 70125400, Recall # Z-0778-2008;
33) CORDIS "Dura Star" 2.25 x 30 Dilatation Catheter, Catalog # 70130225, Recall # Z-0779-2008;
34) CORDIS "Dura Star" 2.50 x 30 Dilatation Catheter, Catalog # 70130250, Recall # Z-0780-2008;
35) CORDIS "Dura Star" 2.75 x 30 Dilatation Catheter, Catalog # 70130275, Recall # Z-0781-2008;
36) CORDIS "Dura Star" 3.00 x 30 Dilatation Catheter, Catalog # 70130300, Recall # Z-0782-2008;
37) CORDIS "Dura Star" 3.25 x 30 Dilatation Catheter, Catalog # 70130325, Recall # Z-0783-2008;
38) CORDIS "Dura Star" 3.50 x 30 Dilatation Catheter, Catalog # 70130350, Recall # Z-0784-2008;
39) CORDIS "Dura Star" 3.75 x 30 Dilatation Catheter, Catalog # 70130375, Recall # Z-0785-2008;
40) CORDIS "Dura Star" 4.00 x 30 Dilatation Catheter, Catalog # 70130400, Recall # Z-0786-2008;
41) CORDIS "Fire Star" 1.50 x 10, Dual Maker Band, Dilatation Catheter, Catalog # 8011015D, Recall # Z-0787-2008;
42) CORDIS "Fire Star" 1.50 x 10, Single Marker Band, Dilatation Catheter, Catalog # 8011015S, Recall # Z-0788-2008;
43) CORDIS "Fire Star" 2.00 x 10, Dual Marker Band, Dilatation Catheter, Catalog # 8011020D, Recall # Z-0789-2008;
44) CORDIS "Fire Star" 2.00 x 10, Single Marker Band, Dilatation Catheter, Catalog # 8011020S, Recall # Z-0790-2008;
45) CORDIS "Fire Star" 2.25 x 10 Dilatation Catheter, Catalog # 80110225, Recall # Z-0791-2008;
46) CORDIS "Fire Star" 2.50 x 10 Dilatation Catheter, Catalog # 80110250, Recall # Z-0792-2008;
47) CORDIS "Fire Star" 2.75 x 10 Dilatation Catheter, Catalog # 80110275, Recall # Z-0793-2008;
48) CORDIS "Fire Star" 3.00 x 10 Dilatation Catheter, Catalog # 80110300, Recall # Z-0794-2008;
49) CORDIS "Fire Star" 3.25 x 10 Dilatation Catheter, Catalog # 80110325, Recall # Z-0795-2008;
50) CORDIS "Fire Star" 3.50 x 10 Dilatation Catheter, Catalog # 80110350, Recall # Z-0796-2008;
51) CORDIS "Fire Star" 1.50 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011515D, Recall # Z-0797-2008;
52) CORDIS "Fire Star" 1.50 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011515S, Recall # Z-0798-2008;
53) CORDIS "Fire Star" 2.00 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011520D, Recall # Z-0799-2008;
54) CORDIS "Fire Star" 2.00 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011520S, Recall # Z-0800-2008;
55) CORDIS "Fire Star" 2.25 x 15 Dilatation Catheter, Catalog # 80115225, Recall # Z-0801-2008;
56) CORDIS "Fire Star" 2.50 x 15 Dilatation Catheter, Catalog # 80115250, Recall # Z-0802-2008;
57) CORDIS "Fire Star" 2.75 x 15 Dilatation Catheter, Catalog # 80115275, Recall # Z-0803-2008;
58) CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Recall # Z-0804-2008;
59) CORDIS "Fire Star" 3.25 x 15 Dilatation Catheter, Catalog # 80115325, Recall # Z-0805-2008;
60) CORDIS "Fire Star" 3.50 x 15 Dilatation Catheter, Catalog # 80115350, Recall # Z-0806-2008;
61) CORDIS "Fire Star" 1.50 x 20, Dual Marker Band , Dilatation Catheter, Catalog # 8012015D, Recall # Z-0807-2008;
62) CORDIS "Fire Star" 1.50 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012015S, Recall # Z-0808-2008;
63) CORDIS "Fire Star" 2.00 x 20, Dual Marker Band, Dilatation Catheter, Catalog # 8012020D, Recall # Z-0809-2008;
64) CORDIS "Fire Star" 2.00 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012020S, Recall # Z-0810-2008;
65) CORDIS "Fire Star" 2.25 x 20 Dilatation Catheter, Catalog # 80120225, Recall # Z-0811-2008;
66) CORDIS "Fire Star" 2.50 x 20 Dilatation Catheter, Catalog # 80120250, Recall # Z-0812-2008;
67) CORDIS "Fire Star" 2.75 x 20 Dilatation Catheter, Catalog # 80120275, Recall # Z-0813-2008;
68) CORDIS "Fire Star" 3.00 x 20 Dilatation Catheter, Catalog # 80120300, Recall # Z-0814-2008;
69) CORDIS "Fire Star" 3.25 x 20 Dilatation Catheter, Catalog # 80120325, Recall # Z-0815-2008;
70) CORDIS "Fire Star" 3.50 x 20 Dilatation Catheter, Catalog # 80120350, Recall # Z-0816-2008;
71) CORDIS "Fire Star" 2.00 x 30, Dual Marker Band, Dilatation Catheter, Catalog # 8013020D, Recall # Z-0817-2008;
72) CORDIS "Fire Star" 2.00 x 30, Single Marker Band, Dilatation Catheter, Catalog # 8013020S, Recall # Z-0818-2008;
73) CORDIS "Fire Star" 2.25 x 30 Dilatation Catheter, Catalog # 80130225, Recall # Z-0819-2008;
74) CORDIS "Fire Star" 2.50 x 30 Dilatation Catheter, Catalog # 80130250, Recall # Z-0820-2008;
75) CORDIS "Fire Star" 2.75 x 30 Dilatation Catheter, Catalog # 80130275, Recall # Z-0821-2008;
76) CORDIS "Fire Star" 3.00 x 30 Dilatation Catheter, Catalog # 80130300, Recall # Z-0822-2008;
77) CORDIS "Fire Star" 3.25 x 30 Dilatation Catheter, Catalog # 80130325, Recall # Z-0823-2008;
78) CORDIS "Fire Star" 3.50 x 30 Dilatation Catheter, Catalog # 80130350, Recall # Z-0824-2008
REASON: Slow Deflation or No Deflation.

CLASS II
MANUFACTURER: Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, Warsaw, IN, by letter dated September 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Recall # Z-0125-2008
REASON: Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.

MANUFACTURER: Cook, Inc., Bloomington, IN, by letter dated August 15, 2007. Firm initiated recall is ongoing.
PRODUCT: THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Recall # Z-0135-2008.
REASON: The device is normally sold as sterile, however this lot was not sterilized and the device is not adequately labeled, as the label does not state whether the device is sterile or non-sterile and lacks the manufacturer's name and address.

MANUFACTURER: General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on March 13, 2007. Firm initiated recall is ongoing.
PRODUCT: GE Healthcare CIC Pro Clinical Information Center, Central Station, Software Version 4.1. (CIC Pro v4.1). (System hardware consists of a processing unit and a monitor), Recall # Z-0280-2008
REASON: Two separate issues may occur with operating The CiC Pro v4.1 System with Telemetry. 1) Experience a loss of audible alarms when operating system memory resource reaches approximately 170MG. This will occur if CIC Pro continuously runs for average of 160 day, and 2) System may continuously reboot upon start up in an attempt to correct the issue.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter. Manufacturer Firm: Siemens Medical Solutions, Erlangen 91052, Germany. Firm initiated recall is complete.
PRODUCT: Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System, Siemens, Recall # Z-0518-2008
REASON: Table may experience a deadlock situation.

MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on May 21, 2007. Manufacturer: Beckman Coulter, Inc. Miami, FL. Firm initiated recall is complete.
PRODUCT: Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Recall # Z-0525-2008
REASON: Sporadic absolute count recovery failures with assayed control cell products when using Lot Number 754801F of the Flow-Count Fluorospheres. Additionally, this lot has experienced secondary fluorescent populations containing more than 20% of the total population, as stated in the Evidence of Deterioration section of the Package Insert.

MANUFACTURER: Recalling Firm: Conmed Corporation, Utica, NY, by letters dated September 10, 2007. Manufacturer: SEISA, Inc., Sarabia Parque Industrial, Juarez, Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) FRAZIER Surgical Suction Instrument, 3 French with Control and Obturator, Product Code: 0031030, 50/C. STERILE, EO, Rx ONLY, Recall # Z-0555-2008;
b) FRAZIER Surgical Suction Instrument, 5 French with Control Vent and Obturator, Product Code: 0031050, 50/C. STERILE, EO, Rx ONLY, Recall # Z-0556-2008;
c) FRAZIER Surgical Suction Instrument, 7 French with Control Vent and Obturator (Bend with Obturator in Place), Product Code: 0031070, 50/C. STERILE, EO, Rx ONLY Recall # Z-0557-2008;
d) FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator, 10 French, Product Code: 0031100, 20/C. STERILE, EO, Rx ONLY, Recall # Z-0558-2008;
e) FRAZIER Surgical Suction Instrument, 8 French with Control Vent and Obturator, Product Code: 0033080, 50/C. STERILE, EO, Rx ONLY, Recall # Z-0559-2008;
f) FRAZIER Surgical Suction Instrument, 10 French with Control Vent and Obturator, Product Code: 0033100, 50/C. STERILE, EO, Rx ONLY, Recall # Z-0560-2008;
g) FRAZIER Surgical Suction Instrument, 12 French with Control Vent and Obturator, Product Code: 0033120, 50/C. STERILE, EO, Rx ONLY, Recall # Z-0561-2008;
h) FRAZIER Surgical Suction Instrument, 18 French with Obturator, Product Code: 0033180, 50/C. STERILE, EO, Rx ONLY, Recall # Z-0562-2008;
i) FRAZIER Olive Tip Suction Instrument, 10 French with Control Vent and Obturator, Product Code: 033110, 50/C. STERILE, EO, Rx ONLY, Recall # Z-0563-2008;
j) POOLE Suction Instrument, Product Code: 0035040, 50/C. STERILE, EO, Rx ONLY, Recall $ Z-0564-2008
REASON: Sterility (package integrity) compromised. The product pouch seal made during assembly of this product, may be incomplete or not present.

MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter dated October 2007. Manufacturer: Medtronic Puerto Rico Operations Co., MedRel, Juncos, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only. (The Medtronic Kinetra Model 7428 Neurostimulator is a multiprogrammable device and a component of the Kinetra Neurostimulator System for deep brain stimulation.), Recall # Z-0693-2008;
b) Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain Stimulation, Rx only, (The Medtronic Activa System in an implantable, multiprogrammable quadripolar system that delivers electrical stimulation to selected areas of the brain), Recall # Z-0694-2008
REASON: Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.

MANUFACTURER: Recalling Firm: Sakar International, Inc., Edison, NJ, by letters on November 30, 2007. Manufacturer: Jp Products Co, Kowloon, Hong Kong. Firm initiated recall is ongoing.
PRODUCT: Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, (LED 3 Step Alcohol Breath Tester) Item Codes: MAX91721, MAX91721CL, MAX91721B, MAX91721-6, MAX91721CL-16, MAX91721CL-FR, MAC91721CL-PDQ and MAX91721B-DW, Recall # Z-0697-2008
REASON: Marketed without a 510(k).

MANUFACTURER: Spectranetics Corporation, Colorado Springs, CO, by letter on December 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Recall # Z-0698-2008
REASON: Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.

MANUFACTURER: Recalling Firm: Arkray USA Inc., Minneapolis, MN, by telephone and email on November 14, 2007. Manufacturer: Apex Biotechnology Corp., Hsinchu, Taiwan. Firm initiated recall is ongoing.
PRODUCT: Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Made in Taiwan, Recall # Z-0699-2008
REASON: Mislabeling: incorrect control range-The Level 1 control solution range printed on the 50-count test strip bottles is incorrect. The range printed on the bottle is 62-54 when it should be 62-94.

MANUFACTURER: Biomet, Inc. Warsaw, IN, by letter dated October 18, 2007. Firm initiated recall is complete.
PRODUCT:
a) Biomet RINGLOC + Instrumentation Impactor Plate, Size 20; REF/Part #: 31-400620, Recall # Z-0700-2008;
b) Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF/Part # 31-400621, Recall # Z-0701-2008;
c) Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Recall # Z-0702-2008;
d) Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Recall # Z-0703-2008;
e) Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Recall # Z-0704-2008;
f) Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Recall # Z-0705-2008
REASON: The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.

MANUFACTURER: Recalling Firm: McKesson Provider Technology, Whippany, NJ, by letter on November 12, 2007. Manufacturer: Medcon LTD, Tel Aviv, Israel. Firm initiated recall is ongoing.
PRODUCT: Horizon Cardiology Hemo Monitoring System; Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50 Hz, Recall # Z-0710-2008
REASON: Power supply reliability: McKesson received word from their manufacturer of the medical grade power supply that some power grade supplies may not provide reliable power output.

MANUFACTURER: Medtronic Cardiac Surgery Technologies, Minneapolis, MN, by letter on November 21, 2007. Firm initiated recall is ongoing.
PRODUCT: Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using Ethylene Oxide. Two, unique jaw curvatures are provided: a standard curve (model 49260) and extra curve (Model 49261). The device is intended for intermittent operation, Recall # Z-0727-2008
REASON: Mechanism failure: Medtronic has identified an issue with four lots of the Cardioblate Gemini-s Surgical Ablation Devices in which the polycarbonate distal coil retainer can fail during the course of a procedure, potentially resulting in an inability to apply the necessary jaw closure force.

MANUFACTURER: Recalling Firm: Fresenius Medical Care North America, Waltham, MA by telephone and certified letter on December 3, 2007. Manufacturer: Fresenius Medical Care North America, Ogden, UT. Firm initiated recall is complete.
PRODUCT: Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, (Hemodialyzer), Recall # Z-0738-2008
REASON: Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.

MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by letters beginning on November 13, 2007. Firm initiated recall is ongoing.
PRODUCT: STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference List for NX Customers, Product Code 15-53231; STERRAD NX System Brochure, Product Code AD-53421-001, Recall # Z-0844-2008
REASON: Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities

MANUFACTURER: Medtronic Image Guided Neurologics, Inc., Melbourne, FL, by personal visits or telephone on October 4, 2007. Firm initiated recall is ongoing.
PRODUCT: Nexframe® Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST, DB-1043, DB-1043-BL, DB-1043-ST, DB-2031, DB-2040-BL, DB-2040-ST, DB-2041, DB-2041-BL, DB-2041-ST, DB-2042, DB-2042-BL, DB-2042-ST, DB-2043, DB-2043-BL, DB-2043-ST, Recall # Z-0849-2008
REASON: Sterility (package integrity) Compromised: Some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. The seal between the inner tray and lid has not been compromised and the contents remain sterile, however, the sterility of the outer surfaces of the inner tray and lid cannot be assured.

MANUFACTURER: Recalling Firm: Inotech Biosystems Intl., Inc., Rockville, MD, by telephone on August 20, 2007. Manufacturer: Connectorate Ag, Dietikon, Switzerland. Firm initiated recall is ongoing.
PRODUCT: Inotech brand Heparin Adsorbent, Catalog #: HA-1, in 10mm x 75mm polystyrene tubes, each containing 70mg of Heparin Adsorbent, 10 tubes per foil lined pouch, 10 foil pouches/box, Recall # Z-0934-2008
REASON: Erroneous Coagulation Tests

MANUFACTURER: Kyphon, Inc., Sunnyvale, CA, by letter on April 25, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Functional Anesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Recall # Z-0948-2008 b) Kyphon, Functional Anesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Recall # Z-0949-2008
REASON: Guidewire Breakages: during the Functional Anesthetic Discography (F.A.D.) procedure.

MANUFACTURER: Medtronic Neuromodulation, Minneapolis, MN, by letter beginning August 3, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic SynchroMed EL Programmable Pumps, Models 8626-10. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0950-2008;
b) Medtronic SynchroMed EL Programmable Pumps, Model 8626L-10. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0951-2008;
c) Medtronic SynchroMed EL Programmable Pumps, Model 8626-18. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0952-2008;
d) Medtronic SynchroMed EL Programmable Pumps, Model 8626L-18. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0953-2008;
e) Medtronic SynchroMed EL Programmable Pumps, Model 8627-10. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0954-2008;
f) Medtronic SynchroMed EL Programmable Pumps, Model 8627L-10. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0955-2008;
g) Medtronic SynchroMed EL Programmable Pumps, Model 8627-18. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0956-2008;
h) Medtronic SynchroMed EL Programmable Pumps, Model 8627L-18. (The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site), Recall # Z-0957-2008
REASON: Pump Motor Stall; pumps can stall due to gear shaft wear.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on November 9, 2007. Manufacturer: Stryker Ireland, Ltd., Orthopedics, County Cork, Ireland. Firm initiated recall is ongoing.
PRODUCT:
a) Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length, 26mm Diameter; Sterile, Forged Vitallium Alloy, Product Number: 6260-5-526; Made in Ireland, Recall # Z-0962-2008;
b) Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter; Sterile, Forged Vitallium Alloy; Product Number: 6260-9-528; Made in Ireland, Recall # Z-0963-2008;
c) Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 32mm DiameterSterile, Forged Vitallium Alloy; Product Number 6260-532; Made in Ireland, Recall # Z-0964-2008;
d) Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6260-9-526, Recall # Z-0965-2008;
e) Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6260-9-528, Recall # Z-0966-2008;
f) Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged Vitallium Alloy Product Number 6260-9-532, Recall # Z-0967-2008;
g) Stryker Trial Head xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Product Number 6268-8-526, Recall # Z-0968-2008;
h) Stryker Trial Head xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6264-8-528, Recall # Z-0969-2008;
i) Stryker Trial Head xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6264-8-532, Recall # Z-0970-2008
REASON: Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.
CLASS III
MANUFACTURER: Xoran Technologies, Inc., Ann Arbor, MI, by letter dated January 4, 2008. Firm initiated recall is ongoing.
PRODUCT: Xoran MiniCAT System for ENT (server and work station), Recall # Z-0826-2008
REASON: Misbranding. The devices do not bear the manufacturer’s name or address.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 6, 2008:

CLASS I
MANUFACTURER: AM2 PAT Inc., Angier, NC, by telephone on or about January 17, 2008 and by press release on January 17, 2008. Firm initiated recall is ongoing.
PRODUCT:
a) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-01, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0827-2008;
b) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0828-2008;
c) B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513611, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0829-2008;
d) Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513612, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0830-2008;
e) Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0831-2008;
f) Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Recall # Z-0832-2008;
g) Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2, 10 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0833-2008;
h) B. Braun, Normal Saline IV Flush, REF #513584, NDC 64054-0903-2, 3 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Recall # Z-0834-2008;
i) B. Braun, Normal Saline IV Flush, REF #513586, NDC 64054-0905-02, 5 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Recall # Z-0835-2008;
j) B. Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Recall # Z-0836-2008;
k) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-02, NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0837-2008;
l) B. Braun, Heparin Lock Flush Solution USP, 10 units/ml, Ref #513610, NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0838-2008;
m) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-02, NDC #64054-3003-02, 3mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0839-2008;
n) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06, NDC #64054-3003-06, 3mL Fill in a 6mL Syringe, 120/Case, For Single Use only,Sterile Solution Pathway, For IV Flush, Recall # Z-0840-2008;
o) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-06, NDC #64054-3005-06, 5mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0841-2008;
REASON: Lack of assurance of sterility by manufacturer.

CLASS II
MANUFACTURER: Philips Medical Systems, Andover, MA, by letter dated September 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Philips Page Writer Touch Cardiograph, Model: 860284, Recall # Z-0124-2008
REASON: Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on February 27, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Siemans Simview 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT Part No: 19 57-161 or without CT Part No. 19 57 153, Recall # Z-0281-2008;
b) Siemans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) Part No. 54 96 992, Recall # Z-0282-2008;
c) Siemans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with CT, Part No: 54 96 984; Recall # Z-0283-2008;
d) Siemans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016, Recall # Z-0284-2008;
e) Siemans Mevasim, with patient table, Part No: 44 81 586, and without patient table Part No: 44-81-669, Recall # Z-0285-2008
REASON: Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated May 30, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems, Gemini TF Product Numbers/Manufacturer Numbers: TF 64 slice: 4535 679 94741, TF 16 slice: 4535 679 83931. Catalog Numbers: TF 64 slice: 882471, TF 16 slice: 882470,
Recall # Z-0461-2008;
b) Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. Gemini GXL Product Numbers/Manufacturer Numbers: 16 slice: 4535 679 71891, 10 slice: 4535 679 75681, 6 slice: 4535 679 75691. Catalog Numbers: 16 slice: 882410, 10 slice: 882400, 6 slice: 882390. Recall # Z-0462-2008
REASON: Artifacts: Artifacts may appear in some images from head scans on the CT subsystem of the GEMINI PET/CT system. Reading images with these artifacts may lead to misdiagnosis or improper treatment.

MANUFACTURER: Recalling Firm: Blackstone Medical, Inc., Wayne, NJ, by telephone, e-mail and fax On May 8, 2006. Manufacturer: Blackstone Medical Inc., Springfield, MA. Firm initiated recall is complete.
PRODUCT: Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; (The Hallmark Anterior Cervical Plate Systems consists of an assortment of implantable titanium alloy plates and bone screws that are provided non-sterile), Recall # Z-0478-2008
REASON: Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification

MANUFACTURER: Vital Images, Inc., Plymouth, MN, by telephone on November 7/8, 2008 and by letter November 8, 2007. Firm initiated recall is ongoing.
PRODUCT: Vital Images ViTALConnect, Version 4.0 and 4.1, PET/CT Visualization option. (A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images), Recall # Z-0520-2008
REASON: Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when a user draws a selected region of interest in order to calculate the SUV statistics of the region. If the user then changes the slice shown by scrolling through additional slices, the original SUV measurements will remain on the screen and do not update with new values for the current slice.

MANUFACTURER: Exocomm Tech Group, Cumming, GA, by letter on September 3, 2007 and October 25, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Recall #Z-0521-2008;
b) life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N: 9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Recall # Z-0522-2008
REASON: Marketed without a 510K

MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Division, McGraw Park, IL, by letter, dated November 14, 2007. Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
PRODUCT: Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software, Recall # Z-0527-2008;
b) Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Recall # Z-0528-2008
REASON: Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only).

MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by letter on September 26, 2007. Firm initiated recall is ongoing.
PRODUCT: Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models, Recall # Z-0554-2008
REASON: Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the Session options during the treatment session. This can lead to difference between the planned and delivered dose distribution for the treatment fraction accepted.

MANUFACTURER: Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter on or about November 15, 2007. Manufacturer: Ethicon Endo-Surgery, Inc. S.A. de C.V. Planta II, Ciudad Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
PRODUCT: Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Recall # Z-0565-2008
REASON: Sterility (package integrity) compromised; damaged packaging may have compromised the sterility of the devices.

MANUFACTURER: Datascope Corp., Mahwah, NJ, by letters on November 19, 2007. Firm initiated recall is ongoing.
PRODUCT: Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Recall # Z-0567-2008
REASON: Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or reset of the display screen during therapy.

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by letter on March 9, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) da Vinci S Surgical System 8 mm instrument cannula, Part #: 420002-01, Recall # Z-0657-2008
b) da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Recall # Z-0658-2008;
c) da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01, Recall # Z-0659-2008
REASON: Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.

MANUFACTURER: Spacelabs Healthcare, Inc., Issaquah, WA, by letters on October 5, 2007, November 30, 2007 and December 7, 2007. Firm initiated recall is ongoing.
PRODUCT: Spacelabs Medical, Ultraview Multigas Analyzer, Model 91518, Recall # Z-0660-2008
REASON: Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by letters on November 19, 2007. Firm initiated recall is ongoing.
PRODUCT: Intuitive brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02, Recall # Z-0669-2008
REASON: Sharp Edges: the 5mm Cannula may have a sharp edge on the inner diameter of the Cannula. The defective cannula may cause particulate shavings to be skive (scraping) from the instrument shafts during surgery.

MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by letter on November 9, 2007. Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
PRODUCT:
a) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector), Recall # Z-0690-2008;
b) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector), Recall # Z-0691-2008;
c) GE Innova 4100 / 4100 IQ. , (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector), Recall # Z-0692- 2008
REASON: Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to send out X-rays without reporting an error message. The result was that the live imaging screen displayed an older "frozen" image until the operator released the pedal. During an intervention, an operator could be misled to believe that the "frozen" image is instead a live dynamic image. This translates to an inability to see/control stent, endo-prosthesis placement, glue injection, or other device placement during an intervention and thus an increased patient risk of catheter, guidewire, glue an/or device misplacement.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated December 12, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Recall # Z-0706-2008;
b) Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Recall # Z-0707-2008
REASON: Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.

MANUFACTURER: Recalling Firm: Aesculap Inc., Center Valley, PA, by letter on or about December 18, 2007. Manufacturer: Aesculap AG & Co. KG, Tuttlingen, Germany. Firm initiated recall is ongoing.
PRODUCT:
a) Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Recall # Z-0708-2008;
b) Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT430T, Casper Applier F/Std Ti-Clipsstr 146 mm, Recall # Z-0709-2008
REASON: Breakage: the inner rod of the applier may corrode and break

MANUFACTURER: Argon Medical Devices, Inc., Athens, TX, by letter on November 15, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG087312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-0882-2008;
b) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-0883-2008;
c) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387308, .035/180cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-0884-2008;
d) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387309, .035/300cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-0885-2008;
e) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387310, .035/150cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-0886-2008;
f) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387311, .035/180cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-0887-2008;
g) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-0888-2008;
h) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387319, .038/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-0889-2008;
i) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387320, .038/180cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-0890-2008;
j) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387324, .038/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-0891-2008
REASON: Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.

MANUFACTURER: Recalling Firm: Boston ScientificMaple Grove, MN, by letter dated November 20, 2007. Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4, PIG 145. 100 and 110 cm Length. Made in Mexico, Recall # Z-0935-2008;
b) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-89. 6F AR MOD (Single Pack). Distal curve AR MOD. 100 cm length, Recall # Z-0936-2008;
c) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-04. 6F FR6 (5-pack). Distal curve FR6. 100 cm length, Recall # Z-0937-2008;.
d) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-195. 6F LCB (5-pack). Distal curve LCB. 100 cm length, Recall # Z-0938-2008;
e) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-202. 6F IM T (t-pack). Distal curve IM T. 100 cm length, Recall # Z-0939-2008;
f) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-86. 6F AR2 (5-pack). Distal curve AR2. 100 cm length, Recall # Z-0940-2008;
g) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-201. 6F IM (5-pack). Distal curve IM. 100 cm length, Recall # Z-0941-2008;
h) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system.Catalog No. 16599-302. 6F MULTI PIG 155 (5-pack). Distal curve FL4, FR4, PIG 155. 100 and 110 cm length, Recall # Z-0942-2008;
i) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-98. 6F AL2 (5-pack). Distal curve AL2. 100 cm length, Recall # Z-0943-2008;
j) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-01. 6F FR3.5 (5-pack). Distal curve FR3.5. 100 cm, Recall # Z-0944-2008,
k) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-03. 6F FR5 (5-pack). Distal curve FR5. 100 cm length, Recall # Z-0945-2008
REASON: Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.

CLASS III
MANUFACTURER: Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by telephone on October 1, 2007 and by letters dated October 5, 2007. Firm initiated recall is ongoing. Manufacturer: Medtronic Mexico, S. De R. L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator, Plasma Resistant Fiber [PRF], (both Model 541T), Recall # Z-0476-2008;
b) Medtronic Blood Collection Reservoir, 40 micron, Catalog/Model # EL240, Recall # Z-0477-2008
REASON: Unapproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Auto transfusion Blood Collection Reservoirs contain components made from an unapproved resin

MANUFACTURER: Cyberonics, Inc., Houston, TX, by letter on October 1, 2007 and November 15, 2007. Firm initiated recall is ongoing.
PRODUCT: Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher, Recall # 0568-2008
REASON: Screen Freezes-- The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the Microsoft 2002 OS and the model Dell X5 handheld computer. Once frozen, the handheld device becomes non-responsive to user input.

MANUFACTURER: Smiths Medical Asd, Inc., Dublin, OH, by letters dated November 19, 2007. Firm initiated recall is ongoing
PRODUCT:
a) Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Recall # Z-0695-2008;
b) Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Recall # Z-0696-2008
REASON: Misbranded. The product codes are labeled incorrectly with a green promotional label for "New split septum sampling site. Only use needle-free access devices .......", however this product code contains a sampling site which is accessed with a shrouded needle, NOT with a needle-free access device.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 30, 2008:

CLASS II
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated September 4, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (Systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38), Recall # Z-0115-2008
REASON: Binding: The instrument was manufactured incorrectly and its use may result in binding to the acetabular component and cause the implant to not release following impaction.

MANUFACTURER: AmniSure International LLC, Cambridge, MA, by letter dated October 1, 2007. Firm initiated recall is ongoing.
PRODUCT: AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, Recall # Z-0120-2008
REASON: Weak true positive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"

MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by letter dated October 1, 2007. Firm initiated recall is ongoing.
PRODUCT: Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs), Recall # Z-0127-2008
REASON: Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens.

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by letter on January 9, 2008. Firm initiated recall is ongoing.
PRODUCT: Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03, Recall # Z-0258-2008
REASON: Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application)

MANUFACTURER: Visx, Inc., Santa Clara, CA, by letter on May 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478, Recall # Z-0365-2008
REASON: Erroneous Treatment Calculations - Two software caused errors; in combination, in the WaveScan System Software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) Installation of software for a certain brand of computer (Dedicated Computing LLC) can cause a software registry setting for an algorithm that identifies image reflection to be erroneously set in the "off" position upon installation on these specific computers, and (2) Software error in the WaveScan System application produces erroneous treatment calculations.

MANUFACTURER: Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by letter dated October 30, 2007. Manufacturer: DePuy ACE S.a.R.L., Le Locle, Switzerland. Firm initiated recall is ongoing.
PRODUCT: a) Depuy TK2 Compression Hip Screw trauma plate, Standard Barrel, 135 Degree, 4H-92.6mm, sterile; REF 8315-35-004, Recall # Z-0434-2008;b) Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104, Recall # Z-0435-2008
REASON: Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel.

MANUFACTURER: Superior Products, Inc., Cleveland, OH, by letter on or about October 19, 207. Firm initiated recall is ongoing.
PRODUCT: Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Recall # Z-0529-2008
REASON: Leakage: Device was leaking oxygen.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated September 14, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5773, Recall # Z-0530-2008;
b) Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5785, Recall # Z-0531-2008;
c) Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo perfusion systems 1, 8000 and 9000; Catalog No: 5791, Recall # Z-0532-2008
REASON: False Alarms: The air sensor may malfunction and trigger false alarms, and may continue to alarm thus preventing the device from being reset.

MANUFACTURER: Ventana Medical Systems, Inc., Tucson, AZ, by letters dated September 30, 2005, June 27, 2006 and September 29, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Benchmark, Slide Staining System, Catalog Number: N750-BMK-FS, Recall # Z-0537-2008;
b) Benchmark XT, Slide Staining System, Catalog Number: N750-BMKXT-FS, Recall # Z-0538-2008;
c) Benchmark LT, Slide Staining System, Catalog Number: N750-BMKLT-FS, Recall # Z-0539-2008;
d) Discovery, Slide Staining System, Catalog Number: N750-DIS-FS, Recall # Z-0540-2008;
e) Discovery XT, Slide Staining System, Catalog Number: N750-DISXT-FS, Recall # Z-0541-2008
REASON: Leaking Carboys/Safety Updates: The Ventana Staining Platform includes one or more carboys that may have the potential to leak if the spigot is either improperly installed or not fully closed.

MANUFACTURER: VNUS Medical Technologies, Inc., San Jose, CA, by letter dated August 6, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Recall # Z-0542-2008;
b) VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Recall # Z-0543-2008
REASON: Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.

MANUFACTURER: Recalling Firm: International Technidyne Corp., Piscataway, NJ, by letter on November 19, 2007. Manufacturer: V Tech Communications Limited, Tai Po, Hong Kong. Firm initiated recall is ongoing.
PRODUCT:
a) ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPRO, Recall # Z-0546-2008;
b) ProTime Microcoagulation System Instrument, Catalogue Number: PROTIMEPST, Recall # Z-0547-2008;
c) ProTime Microcoagulation System Instrument: Catalogue Number: PROTIMEINT, Recall # Z-0548-2008
REASON: An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages.

MANUFACTURER: Recalling Firm: Arrow International, Inc., Reading, PA, by letter dated November, 2007. Manufacturer: Arrow International, Inc., Everett, MA. Firm initiated recall is complete.
PRODUCT: a) ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100,
Recall # Z-0549-2008; b) AutoCAT 2 Series Intra-Aortic Balloon Pumps Catalog No: IAP-0400, IAP-0435, IAP-0500, and IAP-0535, Recall # Z-0550-2008
REASON: Leak may occur in the helium drive system for the IABP.

MANUFACTURER: Recalling Firm: Abbott Laboratories, Inc., Irving, TX, by letters on October 25, 2007. Manufacturer: P.G.P. s.a., Brussels, Belgium. Firm initiated recall is ongoing.
PRODUCT: Abbott, Accelerator Device Manager (ADM); List Number: 08H74-01, Recall # Z-0551-2008
REASON: Sample/Patient Mis-identification: Two issues identified related to the ACCELERATOR Decision Manager (ADM), to include: 1) Sample Identification (SID) and/or Patient Identification (PID) numbers that contain more than 12 characters are truncated to the final 12 characters by the ADM; 2) for SIDs using alpha characters that are case sensitive, SIDs with lower case characters are transmitted by the ADM as upper case characters. Both issues have the potential for sample results to be associated with the incorrect patient.

MANUFACTURER: Aadco Medical, Inc., Randolph, VT, by letter dated November 1, 2007. Firm initiated recall is ongoing.
PRODUCT: AADCO Rayshield Frame Mounted Overhead X-Ray Barrier; Models: E3051AR S-568, 60 x 80 cm Frame Mounted Barrier with Cut-out, E3051AS S-568HL, 60 x 80 cm Frame Mounted Barrier with Cut-out and lamp, E3051AT S-634, 30 x 40 cm Frame Mounted Barrier, E3051AW S-645S, 40 x 50 cm Frame Mounted Barrier, E3051AY S-634HL, 30 x 40 cm Frame Mounted Barrier with lamp, and E3051AZ S-645SHL, 40 x 50 cm Frame Mounted Barrier with lamp, Recall # Z-0552-2008
REASON: Screws may become loose from the mounted shield compromising stability

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter on November 30, 2007. Manufacturer: Baxter Healthcare Corporation, Medication Delivery Division, Irvine, CA. Firm initiated recall is ongoing.
PRODUCT: Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Recall # Z-0588-2008
REASON: Leaking: leaks at the tubing flow restrictor connection to either the coupler or the male luer during filling.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on December 10, 2007. Manufacturer: BD Preanalytical Solutions, Sumter, SC. Firm initiated recall is ongoing.
PRODUCT:
a) BD Vacutainer Push Button Blood collection sets with Pre-Attached Holder; Catalog Number: 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, Recall # Z-0589-2008;
b) BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Pre-attached), Recall # Z-0590-2008
REASON: Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.

MANUFACTURER: Recalling Firm: Hoana Medical, Honolulu, Hawaii, by letter and visit on November 7, 2007. Manufacturer: Sanmina-SCI Corporation, San Jose, CA. Firm initiated recall is complete.
PRODUCT: Hoana LifeBed Patient Vigilance System, (Intelligent Medical Vigilance System),Model Number: 010135-01, Recall # Z-0592-2008
REASON: Bed Exit Failure: Failure to recognize “Bed Exit” when the feature is active due to a software anomaly.

MANUFACTURER: Fertility Technology Resources, Inc., Marietta, GA, by telephone starting September 13, 2007 and by letter on October 9, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Tucker Embryo Catheter, Stylet, for use with Embryo Transfer Catheter, 23 cm, Sterile, Single Use Only, Order #: ftr 223, Recall # Z-0662-2008;
b) Tucker Embryo Catheter, Stylet, for use with Embryo Transfer Catheter, 20 cm, Sterile, Single Use Only, Order #: ftr 220, Recall # Z-0663-2008;
c) Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120, Recall # Z-0664-2008;
d) Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 23 cm, Order #: ftr123, Recall # Z-0665-2008;
e) Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320, Recall # Z-0666-2008;
f) Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Recall # Z-0667-2008
REASON: Expiration Date for Sterility; The 5 year dating could not be validated/supported for sterility assurance.

MANUFACTURER: Organogenesis, Inc., Canton, MA, by telephone on December 26, 2007, letter on December 27, 2007 and by fax on December 31, 2007. Firm initiated recall is ongoing.
PRODUCT: Organogenesis Apligraf, interactive wound and burn dressing, Recall # Z-0675-2008
REASON: Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism

CLASS III
MANUFACTURER: StelKast Co., McMurray, PA, by telephone on October 5, 2007 and by letter on October 9, 2007. Firm initiated recall is complete.
PRODUCT:
a) StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, Recall # Z-0479-2008;
b) StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5, Size 2 Thickness 5 mm, Recall # Z-0480-2008;
c) StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5, Size 3, Thickness 5 mm, Recall # Z-0481-2008;
d) StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5, Size 4, Thickness 5 mm, Recall # Z-0482-2008;
e) StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number: SC2287-5-5, Size 5, Thickness 5 mm, Recall # Z-0483-2008;
REASON: The screws may fracture.

MANUFACTURER: Ventana Medical Systems Inc., Tucson, AZ, by telephone starting in November 2007. Firm initiated recall is ongoing.
PRODUCT: Symphony Staining System (High Volume Stainer), KPA, Model Number 2200000, Recall # Z-0553-2008
REASON: Fluid Leaks-The T fitting located in the Symphony Clear system of the Symphony High Volume Slide Stainer needs to be larger to securely hold the tubing in place to eliminate any possible fluid leak due to the tubing movement.

MANUFACTURER: Recalling Firm: 3M Company / Medical Division, South St Paul, MN, by telephone and letter on October 22, 2007. Manufacturer: 3M Espe Dental Products, Irvine, CA. Firm initiated recall is ongoing.
PRODUCT: 3M ESPE Unitek Stainless Steel Permanent Molar Crowns, Product Code: 900321, Made in U.S.A, Recall # Z-0569-2008
REASON: Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns.

MANUFACTURER: AngioScore Inc., Fremont, CA, by letters on November 9, 2007. Firm initiated recall is ongoing.
PRODUCT: AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5 mm x 10 mm, Recall # Z-0591-2008
REASON: Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton.

he following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 23, 2008:

CLASS II
MANUFACTURER: Datascope Corporation, Fairfieldm, NJ, by Urgent Product Field Correction notices on October 9, 2007.
PRODUCT: Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608; Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Recall # Z-0150-2008
REASON: Display problems: If an ECG cable, which has been damaged due to the ingress of liquid or by mechanical trauma, is utilized with the Telepack, it may cause the Telepack to switch between the 3-lead and 5 lead-input modes. During the switching process, the digital heart rate displayed at the Panorama Central Station will be frozen,

MANUFACTURER: Mini-Mitter Company, Inc., Bend, OR, by letter dated June 26, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM; Actiwatch 64 Part Number 198-0301-00; Actiwatch 64 AM Part Number 198-0301-AM, Recall # Z-0324-2008;
b) Actical with Step, Part Number 198-0302-00, Recall # Z-0325-2008;
c) Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Recall # Z-0326-2008;
d) Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup pkg Part Number 198-1000-00, Recall # Z-0327-2008
REASON: Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.

MANUFACTURER: Recalling Firm: Stryker Endoscopy, San Jose, CA, by recall notice dated April 27, 2007. Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
PRODUCT: SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Recall # Z-0484-2008
REASON: Device Shut off/on: Device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (Patient burns may result from these device malfunctions)

MANUFACTURER: Recalling Firm: General Electric Medical Systems Information Technology, Wauwatosa, WI, by letter on October 16, 2007. Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
PRODUCT: GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems, Recall # Z-0519-2008
REASON: Potential for Loss of Audible Alarming and ECG Tab Setting Changes; from Clinical Information Center (CIC) Pro v5.0.3 & 5.0.6 when used in combination with Telemetry and bedside monitors.

MANUFACTURER: Recalling Firm: Sechrist Industries Inc, Anaheim CA, by letters beginning on November 9, 2007. Manufacturer: Stryker Medical, Div. of Stryker Corp., Portage, MI. Firm initiated recall is ongoing.
PRODUCT:
a) Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Stretcher Model, P/N: 21502, Recall # Z-0733-2008;
b) Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Deluxe Wide Stretcher Model, P/N 21464, Recall # Z-0734-2008;
c) Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Deluxe Wide Stretcher Model, P/N 21465, Recall # Z-0735-2008;
d) Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Standard Stretcher Model, P/N 21466, Recall # Z-0736-2008;
e) Sechrist Hyperbaric Chamber Gurney, Standard Gurney without Side rails & Stretcher Model, P/N 21487, Recall # Z-0737-2008
REASON: Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake.

CLASS III
MANUFACTURER: Biomet 3i, Palm Beach Gardens, FL, by telephone beginning on September 27, 2007. Firm initiated recall is ongoing.
PRODUCT: Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Recall # Z-0128-2008
REASON: Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform.

MANUFACTURER: Nova Biomedical Corp., Waltham, MA, by telephone on September 17, 2007. Firm initiated recall is complete.
PRODUCT: Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Recall # Z-0295-2008
REASON: Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 16, 2008:

CLASS II
MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on July 10, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N: 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for premium edition, Recall # Z-0297-2008;
b) Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054, P/N 05936518 and 10037593, Recall # Z-0298-2008
REASON: Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.

MANUFACTURER: Abbott Laboratories MPG, Abbott Park IL, by letter dated September 18, 2007. Firm initiated recall is ongoing.
PRODUCT: ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59, Recall # Z-0299-2008
REASON: The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that the limit flag should be set no lower than 20 ng/mL

MANUFACTURER: Ventana Medical Systems Inc, Tucson, AZ, by visit beginning September 6, 2007. Firm initiated recall is ongoing.
PRODUCT:
Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Recall # Z-0300-2008
REASON: Devices released prior to full testing; during internal testing it was discovered that the configuration of the Symphony instrument during Hi pot testing procedures does not completely evaluate all components in the test loop.

MANUFACTURER: Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters beginning on October 2, 2007. Manufacturer: Toshiba Corp. Medical Engineering Ctr., Nasu Works, Tochigi, Japan. Firm initiated recall is ongoing.
PRODUCT: Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Recall # Z-0305-2008
REASON: Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.

MANUFACTURER: Encore Medical Lp, Austin, TX, by letter on September 19, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile, Recall # Z-0306-2008;
b) VariLift Bone Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP; Sterile, Recall # Z-0307-2008;
c) VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile, Recall # Z-0308-2008;
d) VariLift Bone Plug w/ End Cap; 11mm Dia, 24mm long; Ref #: CIE1-11-24-BP; Sterile, Recall # Z-0309-2008;
e) VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP; Sterile, Recall # Z-0310-2008;
f) VariLift Bone Plug w/ End Cap; 15mm Dia, 24mm long; Ref #: CIE1-15-24-BP; Sterile, Recall # Z-0311-2008;
REASON: Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications)

MANUFACTURER: Chiu Technical Corp., Kings Park, NY, by letter on November 9, 2007. Firm initiated recall is ongoing.
PRODUCT: Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries, Recall # Z-0320-2008
REASON: Device was marketed without a 510(k).

MANUFACTURER: Dale Medical Products, Inc., Plainville, MA, by letter dated September 27, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Dale 240 Blue (Adults) Trachestomy Tube Holder, Product Number: H84102401, Recall # Z-0446-2008;
b) Dale 242 Blue (Neonate, Infants and Small Children) Trachestomy Tube Holder, Product Number: H84102421, Recall # Z-0447-2008
REASON: Revised Labeling: Instructions For use: "Do not trim fastener hook tabs." Trimming can cause tabs to disengage at the trach plate.

MANUFACTURER: Oasis Medical Inc, Glendora, CA, by letter dated July 18, 2007. Firm initiated recall is ongoing.
PRODUCT:
1) Disposable Angled MVR Blade (23 gauge/0.6mm), REF/Item Code: 1282D0.6, Recall # Z-0485-2008;
2) PremierEdge, MICROSURGICAL KNIFE, 1.2mm, Sideport Knife, REF/Item Code: PE 3012, Recall # Z-0486-2008;
3) PremierEdge, Bulk Microsurgical Knife. 1.2mm, Sideport Knife, Item Code B-PE3012, Recall # Z-0487-2008;
4) PremierEdge, Bulk Microsurgical Knife, 3.0mm Slit Knife, Item Code B-PE3830, Recall # Z-0488-2008;
5) Eyemaxx your choice!, Microsurgical Knife 3.0mm Slit Knife, REF/Item Code: MX2030, MADE IN USA, Recall # Z-0489-2008;
6) PremierEdge, MICROSURGICAL KNIFE,15 DEGREES STAB KNIFE, REF/Item Code: PE 3015, Recall # Z-0490-2008;
7) PremierEdge, MICROSURGICAL KNIFE, 30 DEGREES STAB KNIFE, REF/item Code: PE 3030, Recall # Z-0491-2008;
8) PremierEdge MICROSURGICAL KNIFE, 45 DEGREES STAB KNIFE, REF/Item Code: PE 3045, Recall # Z-0492-2008;
9) PremierEdge MICROSURGICAL KNIFE, 2.5mm Clear Cornea Knife, REF/Item Code: PE 3125; Recall # Z-0493-2008;
10) PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife, Item Code/ REF: PE 3128, Recall # Z-0494-2008;
11) PremierEdge MICROSURGICAL KNIFE, 3.0mm Clear Cornea Knife, Item Code/REF: PE 3130; Recall # Z-0495-2008;
12) PremierEdge MICROSURGICAL KNIFE, 3.2mm Clear Cornea Knife, Item Code/REF: PE 3132; Recall # Z-0496-2008;
13) PremierEdge MICROSURGICAL KNIFE, 2.65mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3226; Recall # Recall # Z-0497-2008;
14) PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3228, Recall # Z-0498-2008;
15) PremierEdge MICROSURGICAL KNIFE, 3.0mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3230, Recall # Z-0499-2008;
16) PremierEdge MICROSURGICAL KNIFE, 2.5-3.0mm Clear Cornea Knife – Trapezoid, Item Code/REF: PE 3302, Recall # Z-0500-2008;
17) PremierEdge MICROSURGICAL KNIFE, 3.2mm Implant Knife, Item Code/REF: PE 3432, Recall # Z-0501-2008;
18) PremierEdge MICROSURGICAL KNIFE, 3.5mm Implant Knife, Item Code/REF: PE 3435, Recall # Z-0502-2008;
19) PremierEdge MICROSURGICAL KNIFE ,4.0mm Implant Knife, Item Code/REF: PE 3440; Recall # Z-0503-2008;
20) PremierEdge MICROSURGICAL KNIFE, 23g MVR Knife, Item Code/REF: PE3523, Recall # Z-0504-2008;
21) PremierEdge MICROSURGICAL KNIFE, 3.0mm Round, Tunnel Knife, Item Code/REF: PE 3630, Recall # Z-0505-2008;
22) PremierEdge MICROSURGICAL KNIFE, 2.0mm Angled Crescent Tunnel Knife, Angled, Item Code/REF: PE 3720A; Recall # Z-0506-2008;
23) PremierEdge MICROSURGICAL KNIFE, 2.65mm Slit Knife, Item Code/REF: PE 3826; Recall # Z-0507-2008;
24) PremierEdge MICROSURGICAL KNIFE, 2.75mm Slit Knife, Item Code/REF: PE 3827; Recall # Z-0508-2008;
25) PremierEdge MICROSURGICAL KNIFE, 2.85mm Slit Knife, Item Code/REF: PE 3828; Recall # Z-0509-2008;
26) PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife, Item Code/REF: PE 3830; Recall # Z-0510-2008;
27) PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife - Straight Item Code/REF: PE 3830S; Recall # Z-0511-2008;
28) PremierEdge MICROSURGICAL KNIFE, 3.2mm Slit Knife; Item Code/REF: PE 3832; Recall # Z-0512-2008;
29) PremierEdge MICROSURGICAL KNIFE, 2.4mm Thin Slit Knife, Item Code/REF: PE 4824-TL; Recall # Z-0513-2008;
30) PremierEdge MICROSURGICAL KNIFE, 2.75mm Thin Slit Knife, Item Code/REF: PE4827-TL; Recall # Z-0514-2008;
31) PremierEdge MICROSURGICAL KNIFE , 2.85mm Thin Slit Knife, Item Code/REF: PE4828-TL; Recall # Z-0515-2008;
32) PremierEdge MICROSURGICAL KNIFE, 3.0mm Thin Slit Knife, Item Code/REF: PE4830-TL; Recall # Z-0516-2008
REASON: Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL.

CLASS III
MANUFACTURER: Recalling Firm: Stryker Communications, Flower Mound, TX, by letter on September 21, 2007. Manufacturer: Extron Electronics, Anaheim, Ca. Firm initiated recall is ongoing.
PRODUCT:
a) Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); (These cables are commonly used with the Switchpoint Infinity II), Recall # Z-0302-2008;
b) Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108); (These cables are commonly used with the SwitchpointInfinity II), Recall # Z-0303-2008
REASON: Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.

MANUFACTURER: Cepheid, Sunnyvale, CA, by letter on September 4, 2007. Firm initiated recall is ongoing.
PRODUCT: Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Recall # Z-0376-2008
REASON: Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 9, 2008:

CLASS I
MANUFACTURER: Cardinal Health 303 Inc DBA Alaris Products, San Diego, CA, by letters on November 5, 2007. Firm initiated recall is ongoing.
PRODUCT: Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100. All Alaris Pump modules shipped prior to September 27, 2007 are subject to this recall. Recall # Z-0460-2008REASON: Inaccurate flow rate; related to misassembled (missing, bent or broken) springs during the manufacturing or servicing of the mechanism assembly.

CLASS II
MANUFACTURER: Siemens Medical Solutions USA Inc., Knoxville, TN, by letter dated June 15, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Recall # Z-0246-2008;
b) Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No. 10097233, Recall # Z-0247-2008;
c) Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Recall # Z-0248-2008;
d) Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728854, Recall # Z-0249-2008;
e) Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573, Recall # Z-0250-2008;
f) Biograph 64-3 Ring, Biograph PET/CT Scanner, Catalog No. 8727450, Recall # Z-0251-2008;
g) Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813, Recall # Z-0252-2008
REASON: Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols).

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letter on July 24, 2007. Firm initiated recall is ongoing.
PRODUCT: Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, (the syringe is packaged in a white box and sealed with a label wrapped around the center of the box-The main analyzer list number is 08H00-01, ), Recall # Z-0301-2008
REASON: Syringe Failure. Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter.

MANUFACTURER: bioMerieux, Inc., Durham, NC, by letter on November 5, 2007. Firm initiated recall is ongoing.
PRODUCT: bioMerieux, BacT/ALERT® FA Culture Bottles, Recall # Z-0457-2008
REASON: Duplicate Bottle Indentification -- Three lot numbers of BacT/ALERT® FA Culture Bottles labels contained duplicate bottle identification (Bottle ID) barcode numbers. (Lots 1017685 and 1017788 contain the same series of Bottle ID's; Lot 1017693 contains duplicate Bottle ID's within the lot and may share Bottle ID's with both lots 1017685 and 1017788)

MANUFACTURER: Recalling Firm: Marknew Products, Santa Fe Springs, CA, by letters on November 27, 2007. Manufacturer: Haeng Lim Seo Won, Wonmiku Buchon, Korea, Republic Of (South). Firm initiated recall is ongoing.
PRODUCT: HAENG LIM --Acupuncture Needles- PRE-STERILIZED GAMMA-RAY; 100 Packages (10 Needles/Package-1,000 needles in each box), Recall # Z-0566-2008
REASON: Marketed without 510(k)

CLASS III
MANUFACTURER: Nicolet Biomedical Division of Viasys Healthcare, Madison, WI, by letter on September 11, 2007. Firm initiated recall is ongoing.
PRODUCT: Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing Axiomtek Panel PC computer system), released and installed between December 2004 and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part Numbers: 842-673800, 842-673900, 982A0421 and
982A0422, Recall # Z-0126-2008
REASON: Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 2, 2008:

CLASS II

MANUFACTURER: Ellex, Inc., Sacramento, CA, by letter on September 25, 2007. Firm initiated recall is ongoing.
PRODUCT: Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Recall # Z-0148-2008
REASON: Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations. Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations.

MANUFACTURER: Rita Medical Systems, Inc., Manchester, GA, by letters beginning on October 3, 2007 and October 9, 2007. Firm initiated recall is ongoing.
PRODUCT: Vortex® VX, Port System, 9.6FR, REF/Part Number: P5455K, Catalog Number: P5455, Latex Free, Sterile, Recall # Z-0149-2008
REASON: The product may contain an incorrect size catheter.

MANUFACTURER: Recalling Firm: Precept Medical Products, Inc., Arden, NC, by letters on September 14, 2007 and October 4, 2007. Manufacturer: Precept Medical Products Inc, Childersburg, AL. Firm initiated recall is ongoing.
PRODUCT:
a) Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free, Reorder #: 65-3322, non-sterile, 50/box, 5 box/case, Recall #: Z-0153-2008;
b) Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, Reorder #: 65-3320, non-sterile, 25/box, 6 box/case, Recall # Z-0154-2008
REASON: Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff.

MANUFACTURER: Medtronic Sofamor Danek USA Inc, Memphis, TN, by e-mail on September 12, 2007, by hand delivery on September 13, 2007 and by letter dated October 25, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic binder, Recall # Z-0192-2008;
b) Satellite Spinal System Surgical Technique, LITSATFUSST7-IRN10612/087, and LIT (DRAFT) Medtronic, Recall # Z-0193-2008;
c) Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size 9 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0194-2008;
d) Medtronic Sofamor Danek, 10 mm Satellite Sphere CoCr, Size 10 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0195-2008;
e) Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Size 11 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0196-2008;
f) Medtronic Sofamor Danek, 12 mm Satellite Sphere CoCr, Size 12 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0197-2008;
g) Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Size 13 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0198-2008;
h) Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Size 14 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0199-2008;
i) Medtronic Sofamor Danek, 15 mm Satellite Sphere CoCr, Size 15 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0200-2008;
j) Medtronic Sofamor Danek, 16 mm Satellite Sphere CoCr, Size 16 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0201-2008;
k) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0202-2008;
l) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 11 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0203-2008;
m) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 12 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0204-2008;
n) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 13 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0205-2008;
o) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 14 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0206-2008;
p) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 15 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0207-2008;
q) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 16 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0208-2008;
r) Medtronic Sofamor Danek, 8 mm Curette, size 8 mm, Material Stainless Steel/Radel, quantity 1 each, Non-sterile, Rx only, Recall # Z-0209-2008;
s) Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material Stainless Steel/Radel, quantity 1 each, Non-sterile, Rx only, Recall # Z-0210-2008
REASON: Marketed without approval: The surgical technique includes reference to an 8mm Trial and 8mm Curette, while the cleared -510 (k)- device only includes spheres between 9.5 and 19 mm.

MANUFACTURER: Recalling Firm: Teleflex Creek Dr. Durham, NC, by letter on/about August 22, 2007. Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing.
PRODUCT: HUDSON RCI®, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Recall # Z-0211-2008
REASON: Decreased in flow output; through the nebulizer - (when used at higher oxygen concentration settings, this decrease in flow, may lower the oxygen concentration inspired by the patient).

MANUFACTURER: Recalling Firm: Beckman Coulter Inc, Brea, CA, by letters on April 18, 2007. Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
PRODUCT:
a) COULTER LH750 Analyzer, Part Number: 6605632, Hematology analyzer, Recall # Z-0312-2008;
b) COULTER LH780 Analyzer, Part Number: 723585, Hematology analyzer, Recall # Z-0313-2008;
c) COULTER LH 500 Series System, Part Number: 178833, Hematology analyzer, Recall # Z-0314-2008;
d) COULTER GEN*S System, Part Number: 6605381, Hematology analyzer, Recall # Z-0315-2008
REASON: Patient Mis-identification can occur: 1) - When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier.
2) - When manually entering a Patient ID, if a blank space is entered between the characters in the Patient ID field, the system will only accept the characters before the space.

MANUFACTURER: Biomet, Inc. Warsaw, IN, by letter dated September 21, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Recall # Z-0318-2008;
b) Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Recall # Z-0319-2008
REASON: Loose Screw Component: A screw may come loose and fall from the device during use, and result in implantation with the bone cement.

MANUFACTURER: Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letter on September 10, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. (The product is a software application that is installed in Philips Medical System CT scanners.), Recall # Z-0366-2008;
b) Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Brilliance CT scanners using software versions 2.0 through V 2.2.5 and all EBW workstations using software versions 2.0 through V3.5.2. (The product is a software application that is installed in Philips Medical System CT scanners.) Recall # Z-0367-2008
REASON: Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or on a PACS System.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter on November 14, 2007. Manufacturer: Microgenics Corp., Fremont, CA. Firm initiated recall is ongoing.
PRODUCT
a) Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog No. 20751995190, Recall # Z-0377-2008;
b) Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog No. 20752401190, Recall # Z-0378-2008;
c) Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical chemistry analyzers; Catalog No. 20753009190, Recall # Z-0379-2008;
REASON: High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.

MANUFACTURER: Microbiologics, Inc., Saint Cloud, MN, by telephone and letter on October 17, 2007. Firm initiated recall is ongoing.
PRODUCT: MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P), Recall # Z-0456-2008
REASON: Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.

MANUFACTURER: BatteryZone, Inc., Somerset, NJ, by letters on September 3, 2007 and letter dated October 25, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium; Sulfur Dioxide, OEM P/N: 9146-001, voltage 12V, 7.5 amps, Part #: 7L877, Recall # Z-0523-2008
b) Life+cel, Replacement battery for Cardiac Science FirstSave Survivalink, Lithium Sulfur Dioxide, Voltage 12V, 7.5 Amps, OEM P/N: 9141-001, Part Number: 2L561, Recall # Z-0524-2008
REASON: Marketed without 510 (K) approval.

MANUFACTURER: Recalling Firm: Ambu Inc, Glen Burnie, MD, by letters dated August 21, 2007 and November 29, 2007. Manufacturer: Ambu A/S, Ballerup, Denmark. Firm initiated recall is ongoing.
PRODUCT
a) Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, Catalog Number: A000137000, Recall # Z-0533-2008
b) Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, Catalog Number: A000138000, Recall # Z-0534-2008
c) Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, Catalog Number: A137001000, Recall # Z-0535-2008
d) Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, Catalog Number: A137000501, Recall # Z-0536-2008
REASON: Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 26, 2007:

CLASS II
MANUFACTURER: OrthoHelix Surgical Designs Inc, Akron, OH, by letter on Sept. 4, 2007. Firm initiated recall is ongoing
PRODUCT:
a) DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate;
b) Distal Screw Part Numbers: DRV-021-24-10, -12, -14, -16, -18, -20, -22 and -24;
c) Distal Peg Part Number: DRV-121-20-10, -12, -14, -16, -18, -20, -22, and -24; All screw caddies and any distal screw and peg inventory not yet added to screw cadies, Recall # Z-0136-2008
REASON: Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.

MANUFACTURER: Freedom Designs Inc, Simi Valley, CA, by letter on May 15, 2007. Firm initiated recall is ongoing.
PRODUCT: Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Recall # Z-0137-2008
REASON: Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over.

MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter and e-mail on September 4, 2007. Manufacturer: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, Size 6 X 12, MATL: Steel/Titanium, Rx only,
Recall # Z-0138-2008;
b) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, Size 6 X 14, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0139-2008;
c) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972266, Size 6 X 16, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0140-2008;
d) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, Size 7 X 14, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0141-2008;
e) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972267, Size 7 X 16, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0142-2008;
f) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972287, Size 7 X 18, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0143-2008
REASON: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.

MANUFACTURER: Gen-Probe Inc, San Diego, CA, by telephone on May 2nd and 3rd, 2007 and by letter on May 3, 2007. Firm initiated recall is complete.
PRODUCT: Accuprobe Group B Streptococcus Culture Identification Test, Catalog number: 2820B, Batch number: 531379, Recall # Z-0145-2008
REASON: Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches

MANUFACTURER: Encore Medical, Lp, Austin, TX, by telephone and letter on August 8, 2007. Firm initiated recall is complete.
PRODUCT: a) Encore® Reverse® Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert, Catalog #: 508-00-036, Sterile, Recall # Z-0184-2008;
b) Encore® Reverse® Shoulder Prosthesis (RSP) System, Standard Size 40 RSP
Humeral Socket Insert, Catalog #: 508-00-040, Sterile, Recall # Z-0185-2008;
REASON: Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.

MANUFACTURER: Recalling Firm: Ellex USA, Eden Prairie, MN, by telephone on June 13, 2007 and by letters on September 27, 2007. Manufacturer: Ellex Medical Pty Ltd, Adelaide, SA Australia. Firm initiated recall is ongoing.
PRODUCT:
a) Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - DGS P/N 303896; Solitaire-SGS P/N 3038960, Recall # Z-0286-2008;
b) Ellex Integre Duo, Model No: LP1RG -S P/N 3040000. The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient
clinic, or a retinal specialist's office, Recall # Z-0287-2008
REASON: Electric Shock from Power Supply: The power supply has a defect which can cause an electrical shock to user.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated September 11, 2007. Manufacturer: Danish Diagnostic Dev. A/S, Hrsholm, Denmark. Firm initiated recall is ongoing.
PRODUCT: C.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed), Model No: 9VIR1200, Recall # Z-0304-2008
REASON: Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 19, 2007:

CLASS II
MANUFACTURER: Recalling Firm: Global Protection Corp., Boston, MA, by e-mail on September 11, 2007. Manufacturer: Guilin Latex Factory, Guilin, Guangxi, China. Firm initiated recall is complete.
PRODUCT: Lubricated Latex Condom. Labeled in part: “Coming Together in DC”, Recall # Z-0054-2008
REASON: Condoms fail the water leak test and package integrity.

MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek USA, Inc, Memphis, TN, by letters on August 24, 2007. Manufacturer: Warsaw Orthopedic, Inc., dba Medtronic SOFAMOR DANEK, Warsaw, IN. Firm initiated recall is complete.
PRODUCT: Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Recall # Z-0074-2008
REASON: Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cement Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Recall # Z-0123-2008
REASON: Mislabeled as to size. Labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

MANUFACTURER: VNUS Medical Technologies, Inc, CA, by letters on March 6, 2007. Firm initiated recall is complete.
PRODUCT: VNUS ClosureFAST catheters, Model number: CL7-7-100, Recall # Z-0132-2008
REASON: Sterility (package integrity) Compromised. Product sterility may be compromised due to a pinhole under the pouch foldover.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letters on September 17, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10, Recall $ Z-0146-2008;
b) ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10, Recall # Z-0147-2008
REASON: Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of the Robotic Sample Handler.
MANUFACTURER: Mizuho Orthopedic Systems, Inc., Union City, CA, by letter and telephone on February 28, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Recall # Z-0241-2008;
b) OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic
Surgery Table-- Stand alone single-pedestal AC power or battery operated table, Recall # Z-0242-2008
REASON: Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.

MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by letter letters dated September 10, 2007. Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
PRODUCT: GE Healthcare Advantage Workstations, Advantage Workstation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2, Recall # Z-0265-2008
REASON: Aortic Length over-estimated: Incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the customized protocols for an aneurysm should not be used.

MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated June 30, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Recall # Z-0316-2008;
b) Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Recall # Z-0317-2008
REASON: Clip Detachment. The retainer c-clip can detach from the instrument during use and may fall into the surgical wound.

MANUFACTURER: Axya Medical, Beverly, MA, by letter dated September 25, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Axya Bone Anchor , 3.0 mm Titanium with Nylon Suture Catalog Number: CAT1226, Recall # Z-0331-2008;
b) Axya Bone Anchor, 5.0 mm Titanium with Nylon Suture Catalog Number: CAT1227, Recall # Z-0332-2008;
c) Axya Bone Anchor, 6.5 mm Titanium with Nylon Suture, Catalog Number: CAT1238, Recall # Z-0333-2008;
d) Axya Bone Anchor 3.0 mm Titanium with UHMWPE Suture Catalog Number: CAT1268, Recall # Z-0334-2008;
e) Axya Bone Anchor 5.0 mm Titanium with UHMWPE Suture Catalog Number: CAT1269, Recall # Z-0335-2008;
f) Axya Anchor, 5.0 mm Titanium in Super Kit, Catalog Number: CAT1270, Recall # Z-0336-2008;
g) Axya Bone Anchor 3.0 mm Titanium in Super Kit Catalog Number: CAT1274, Recall # Z-0337-2008;
h) Axya Bone Anchor, 3.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1230, Recall # Z-0338-2008;
i) Axya Bone Anchor 5.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1234, Recall Z-0339-2008;
j) Axya Bone Anchor 6.5 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1264, Recall # Z-0340-2008;
k) Axya Bone Anchor 6.5 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1265, Recall # Z-0341-2008;
l) Axya Bone Anchor 3.0 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1266, Recall # Z-0342-2008;
m) Axya Bone Anchor 5.0 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1267, Recall # Z-0343-2008;
n) Axya Bone Anchor, 5.0 mm Bioabsorbable in Super Kit, Catalog Number: CAT1271, Recall Z-0344-2008;
o) Axya Bone Anchor 3.0 mm Bioabsorbable in Super Kit Catalog Number: CAT1273, Recall # Z-0345-2008;
p) Arthocare 5mm ParaFix Anchor (5mm x 14.5mm) -2 strands of #2 braided suture, Part Number: 22-5001, Recall # Z-0346-2008;
q) Arthocare 3mm ParaFix Anchor (3mm x 9mm) -single strand of #2 braided suture,Part Number: 22-5002, Recall # Z-0347-2008;
r) Arthrocare 3mm ParaFix Anchor, single strand of Magnum Wire,Part Number: 22-5010, Recall # Z-0348-2008;
s) Arthrocare 5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5011, Recall # Z-0349-2008;
t) Arthrocare 6.5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5012, Recall # Z-0350-2008;
u) Arthrocare 3.0mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5030, Recall Z-0351-2008;
v) Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055, Recall # Z-0352-2008;
w) Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number: 22-5055N, Recall # Z-0353-2008;
x) Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, Recall # Z-0354-2008;
y) Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number:22-5065N, Recall # Z-0355-2008
REASON: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging.

MANUFACTURER: Recalling Firm: Stryker Medical Div. of Stryker Corp., Portage, MI, by letter dated November 2, 2007. Manufacturer: Stryker Medical Quebec, LP, L'Isletville, Canada. Firm initiated recall is ongoing.
PRODUCT:
a) Stryker inTouch Critical Care bed; Model 2130, Recall # Z-0356-2008;
b) Stryker inTouch Zoom Critical Care bed, Model 2140, Recall # Z-0357-2008
REASON: Multiple defects: 1) beds exhibit reverse motions when the Fowler, gatch or foot section is activated; 2) a battery charging defect which may result in a depletion of battery power; 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access; 4) beds equipped with zoom drive systems may have an overdrive problem which could result in the bed not being readily movable.

MANUFACTURER: Haemonetics Corp., Braintree, MA, by letter on October 15, 2007. Firm initiated recall is ongoing.
PRODUCT: Haemonetics cardioPAT System. Product list number 02050, (Cardiovascular Perioperative Autotransfusion), Recall # Z-0358-2008
REASON: Labeling (additional) use instructions to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient’s chest.

MANUFACTURER: Acist Medical Systems, Eden Prairie, MN, by letter on October 3 and 4, 2007, Firm initiated recall is ongoing.
PRODUCT: ACIST Multi-Use Syringe Kit, Model A2000; SKU #: 014612; labeled as STERILE; Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly), Recall # Z-0359-2008
REASON: Syringe Fracture: The syringe may be fractured, causing contrast to be sprayed from syringe fracture.

MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone on November 13, 2006. Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is complete.
PRODUCT: VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Recall # Z-0361-2008
REASON: Labeling Error: The VKS PE Ultra-congruent insert package may actually contain a Standard PE insert.

MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone on Nov. 27, 2007 Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is complete.
PRODUCT: VKS Tibial Trial, Right/Left, Prep Guide, Recall # Z-0362-2008
REASON: The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter.

MANUFACTURER: Recalling Firm: Blackstone Medical, Inc., Wayne, NJ, by phone, e-mail and fax on April 30, 2007. Manufacturer: Blackstone Medical Inc., Springfield, MA. Firm initiated recall is complete.
PRODUCT: Ascent POCTS (Posterior Occipital Cervical Thoracic System). Recall # Z-0363-2008
REASON: Manufacturing Defect: The saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. The extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. As a consequence, there is a potential for set-screw cross-threading during implantation. Cross-threading could in turn lead to a compromise of the integrity of the multi-axial locking mechanism.

MANUFACTURER: Accuray Inc, Sunnyvale, CA, by Urgent Advisory Notification on March 20, 2007. Firm initiated recall is ongoing.
PRODUCT: Accuray, Multiplan Treatment Planning Software, Recall # Z-0364-2008
REASON: Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.

MANUFACTURER: Recalling Firm: Abbott Point of Care Inc., East Windsor, NJ.
Manufacturer: Abbott Point Of Care, Mississauga, Canada, Firm initiated recall is ongoing
PRODUCT:
a) Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct), Recall # Z-0370-2008
b) Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct), Recall # Z-0371-2008
c) Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct), Recall # Z-0372-2008
d) Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea), Recall # Z-0373-2008
e) Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct), Recall # Z-0374-2008
f) Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu), Recall # Z-0375-2008
REASON: Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed

MANUFACTURER: Recalling Firm: Aesculap Implant Systems, Center Valley, PA, by letter dated Oct. 10, 2007. Manufacturer: Aesculap AG & Co. KG., Tuttlingen, Germany, Firm initiated recall is complete.
PRODUCT:
a) Excia Cemented Hip Stems, Size 9mm, Recall # Z-0436-2008;
b) Excia Cemented Hip Stems, Size 10mm, Recall # Z-0437-2008;
c) Excia Cemented Hip Stems, Size 11mm, Recall # Z-0438-2008;
d) Excia Cemented Hip Stems, Size 12mm, Recall # Z-0439-2008;
e) Excia Cemented Hip Stems, Size 13mm, Recall # Z-0440-2008;
f) Excia Cemented Hip Stems, Size 14mm, Recall # Z-0441-2008;
g) Excia Cemented Hip Stems, Size 15mm, Recall # Z-0442-2008;
h) Excia Cemented Hip Stems, Size 16mm, Recall # Z-0443-2008;
i) Excia Cemented Hip Stems, Size 17mm, Recall # Z-0444-2008;
j) Excia Cemented Hip Stems, Size 18mm, Recall # Z-0445-2008
REASON: Sterility (package integrity) Compromised: Device package damaged during shipment.

MANUFACTURER: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letter on September 19, 2006. Firm initiated recall is complete.
PRODUCT:
a) Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Recall # Z-0448-2008;
b) Triathlon MIS Femoral Adjustment Block; Catalog Number: 6541-5-601, Recall # Z-0449-2008;
c) Triathlon MIS Modular Capture; Catalog Number: 6541-5-723, Recall # Z-0450-2008
REASON: Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly.

MANUFACTURER: Philips Medical Systems, Andover, MA, by letter dated November 2007. Firm initiated recall is ongoing.
PRODUCT: Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Recall Z-0451-2008
REASON: Alarm failure: If changes are made to the Care Group Editor configuration, Care Group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the Care Group

MANUFACTURER: Recalling Firm: ConMed Electrosurgery, Centennial, CO, by letter on November 2, 2007. Manufacture: ConMed Corporation, Utica, NY. Firm initiated recall is ongoing.
PRODUCT: Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers: 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Recall # Z-0452-2008
REASON: Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal.

MANUFACTURER: Becton Dickinson and Company, Waltham, MA, by letter and telephone on November 20, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in), Sterile, Catalog #/REF #: 585155, Recall Z-0453-2008;
b) BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #: 585793, Recall # Z-0454-2008
REASON: No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated August 30, 2007. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
PRODUCT: Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightCycler instruments or systems **,LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732, Recall # Z-0459-2008
REASON: False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries showed up to a 40% reduction in signal.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 28, 2007. Manufacturer: Benoist, Herouville, St Clair, France. Firm initiated recall is ongoing.
PRODUCT:
a) Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm; Sterile; IMPLANT SIZE 1, Recall # Z-0463-2008;
b) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-002, IMPLANT SIZE 2, Sterile, Recall # Z-0464-2008;
c) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-003, IMPLANT SIZE 3, Sterile; Recall # Z-0465-2008;
d) Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-004, IMPLANT SIZE 4, Sterile; Recall # Z-0466-2008;
e) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-005, IMPLANT SIZE 5, Sterile; Recall # Z-0467-2008;
f) Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-006, IMPLANT SIZE 6 , Recall # Z-0468-2008;
g) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-007, IMPLANT SIZE 7, Recall # Z-0469-2008;
h) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-008, IMPLANT SIZE 8, Recall # Z-0470-2008;
i) V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-009, IMPLANT SIZE 9, Recall # Z-0471-2008;
j) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-010, IMPLANT SIZE 10, Recall # Z-0472-2008;
k) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-011, IMPLANT SIZE 11 , Recall # Z-0473-2008;
l) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-012, IMPLANT SIZE 12, Recall # Z-0474-2008
REASON: Mis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters dated October 17, 2007. Manufacturer: Benoist, Herouville St Clair, France. Firm initiated recall is ongoing.
PRODUCT: Hipstar TMZF Cementless Hip Stem Protocol, Product number: LSP60, Recall # Z-0475-2008
REASON: Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of + 12 should have been omitted.

CLASS III
MANUFACTURER: Arkray USA, Inc., Minneapolis, MN, by letter on October 18, 2007 and October 26, 2007. Firm initiated recall is ongoing.
PRODUCT: Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, (Package Contents -Advance Micro-draw Blood Glucose Meter, 10 test Strips, Coding chip and Control Solution (3mL), Lancing device, 10 Lancets, 3V Lithium Battery, Logbook, User Instruction Manual, Quick Reference Guide), Recall # Z-0458-2008
REASON: Mis-labeled/coded strips: Meter kits from this lot contain mislabeled 10-count test strip vials. The code number printed on the Advance Micro-draw 10-count test strip bottle is incorrect. The code number on the vial is 867 when it should be 687. The 687-labeled code chip contains the correct calibration information for the "867" test strips, so the meter will function properly and give accurate results if the "687" code chip and "867" test strips are used together. However to minimize possibility for confusion or inconvenience by the end user, ARKRAY has decided to recall the product.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 12, 2007:

CLASS II
MANUFACTURER: Biomet, Inc. Warsaw, IN, by letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Recall # Z-0123-2008
REASON: Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

MANUFACTURER: Recalling Firm: Arjo, Inc. Roselle IL, by letter on October 15, 2007. Manufacturer: Arjo Hospital Equipment, Esloev, Sweden. Firm initiated recall is ongoing.
PRODUCT: Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift, Recall # Z-0261-2008
REASON: Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.

MANUFACTURER: Recalling Firm: Straumann USA LLC, Andover, MA, by letters on September 28, 2007 Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.
PRODUCT: a) Straumann Palatal Implant, 04.1 L 4.2 mm, Article Number: 042.335S,
Recall # Z-0277-2008; b) Straumann Palatal Implant, 4.8 L 4.2 mm, Article Number: 042.336S, Recall # Z-0278-2008
REASON: Sticking Transfer Piece. The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.

MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter dated September 10, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Recall # Z-0321-2008;
b) Terumo Advanced Perfusion System, 1 Roller Pump, 6 inch diameter; Catalog No. 801041, Recall # Z-0322-2008
REASON: Failure to Operate: The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.

MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter dated September 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number: 801046, Recall # Z-0323-2008
REASON: Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.

MANUFACTURER: Boston Scientific Corp, Spencer, IN, by letter on July 19, 2007. Firm initiated recall is complete.
PRODUCT: Boston Scientific Accustick II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF, Recall # Z-0328-2008
REASON: Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Bothell, WA, by letter dated September 21, 2007. Manufacturer: Philips Medical Systems Netherlands, Best, Netherlands. Firm initiated recall is ongoing.
PRODUCT:
a) Allura Xper FD20 X-Ray System, Release 2.2, Recall # Z-0329-2008;
b) Allura Xper FD20/10, Release 1.2, Recall # Z-0330-2008
REASON: Inaccurate anatomical measurements when using the optional SmartMask feature.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter dated December 6, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High Energy Medical Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel Positioners, Recall # Z-0380-2008;
b) Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners,
Recall # Z-0381-2008;
c) Siemens, Oncor Impression, Part No.: 58 57 920, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Recall # Z-0382-2008;
d) Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners,
Recall Z-0383-2008;
e) Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners,
Recall Z-0384-2008
REASON: Products collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.

MANUFACTURER: Depuy Orthopedics, Inc., Warsaw, IN, by letters dated September 27, 2007. Firm initiated recall is ongoing.
PRODUCT:
1) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430, Recall # Z-0385-2008;
2) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0431,
Recall # Z-0386-2008;
3) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0432;
Recall # Z-0387-2008;
4) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0433,
Recall # Z-0388-2008;
5) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0440,
Recall # Z-0389-2008;
6) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 10.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0441,
Recall # Z-0390-2008;
7) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-0442,
Recall # Z-0391-2008;
8) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0451, Recall # Z-0392-
2008;
9) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 12.5 mm, 4, UHMWPE, sterile; Product Code/REF 96-0452,
Recall # Z-0393-2008;
10) Depuy P.F.C. ® E Knee SystemStabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 15.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0453,
Recall # Z-0394-2008;
11) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 89 mm M/L, 59 mm A/P, 10.0 mm, 6, UHMWPE, sterile; Product Code/REF 96-0471,
Recall # Z-0395-2008;
12) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521,
Recall # Z-0396-2008;
13) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522,
Recall # Z-0397-2008;
14) Depuy P.F.C. ® E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product
Code/REF 96-0523, Recall # Z-0398-2008;
15) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527,
Recall # Z-0399-2008;
16) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544, Recall # Z-0400-
2008;
17) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551, Recall # Z-0401-
2008;
18) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630,
Recall # Z-0402-2008;
19) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640,
Recall # Z-0403-2008;
20) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641,
Recall # Z-0404-2008;
21) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650,
Recall # Z-0405-2008;
22) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651,
Recall # Z-0406-2008;
23) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF
96-0663, Recall # Z-0407-2008;
24) Depuy P.F.C. ® E RP Knee System Rotating Platform Curved Tibial Insert (RP-CVD), 10mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2041,
Recall # Z-0408-2008;
25) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5mm, Size 2.5, UHMWPE, sterile; Product Code/REF 96-2122,
Recall # Z-0409-2008;
26) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2131,
Recall # Z-0410-2008;
27) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2132,
Recall # Z-0411-2008;
28) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 15 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2133,
Recall # Z-0412-2008;
29) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2134,
Recall # Z-0413-2008;
30) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert(RP-STAB), 10 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2141,
Recall # Z-0414-2008;
31) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2142,
Recall # Z-0415-2008;
32) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2161,
Recall # Z-0416-2008;
33) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2164,
Recall # Z-0417-2008;
34) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, 3, UHMWPE, sterile; REF Product Code/96-2643,
Recall # Z-0418-2008;
35) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4, UHMWPE, sterile; Product Code/REF 96-2650,
Recall # Z-0419-2008;
36) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652,
Recall # Z-0420-2008;
37) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 15 mm, 2, UHMWPE, sterile; Product Code/REF 96-2712,
Recall # Z-0421-2008;
38) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 17.5 mm, 2, UHMWPE, sterile; Product Code/REF 96-2713,
Recall # Z-0422-2008;
39) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 10 mm, 3, UHMWPE, sterile; Product Code/REF
96-2730, Recall # Z-0423-2008;
40) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF
96-2731, Recall # Z-0424-2008;
41) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 15 mm, 3, UHMWPE, sterile; Product Code/REF
96-2732, Recall # Z-0425-2008;
42) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS),71 mm M/L, 47 mm A/P, 17.5 mm, 3, UHMWPE, sterile; Product Code/REF
96-2733, Recall # Z-0426-2008;
43) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 25 mm, 3, UHMWPE, sterile; Product Code/REF
96-2736, Recall # Z-0427-2008;
44) Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 3, 11.5 mm, sterile; Product Code/REF 1498-11-310, Recall # Z-0428-2008;
45) Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile; Product Code/REF 1498-11-410, Recall # Z-0429-2008;
46) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 7.0 mm, sterile; Product Code/REF 1498-12-206, Recall # Z-0430-2008;
47) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 9.5 mm, sterile; Product Code/REF 1498-12-208, Recall # Z-0431-2008;
48) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 4, 7.0 mm, sterile; Product code/REF 1498-12-406, Recall # Z-0432-2008;
49) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 5, 7.0 mm, sterile; Product code/REF 1498-12-506, Recall # Z-0433-2008;

REASON: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
CLASS III
MANUFACTURER: Boston Scientific Corp., Miami, FL, by letter on June 14, 2007. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific Target, Transend EX Soft Tip Guide Wire .014 in /205cm, UPN: M001468060, Catalog Number: 46-806, Recall # Z-0122-2008
REASON: Mislabeling. Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.

MANUFACTURER: Recalling Firm: Boston Scientific Corp., Natick, MA, by letter on October 12, 2007.Manufacturer: TFX Engineering Ltd., Teleflex Medical, Limerick, Ireland. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Recall # Z-0279-2008
REASON: Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 5, 2007:

CLASS II
MANUFACTURER: Cyberonics, Inc., Houston, TX, by correction notice in June of 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Cyberonics Neuro Cyberonics Prothesis System NCP Bipolar Lead, Model #300; Sterile, Single use only, Z-0171-2008;
b) Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only, Recall # Z-0172-2008;
c) Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only, Recall # Z-0173-2008
REASON: Dissolution/Fractures to the leads of the VNS Therapy System.

MANUFACTURER: Recalling Firm: Oridion Capnography Inc., Needham Heights, MA, by letters dated, August 21, 2007. Manufacturer: Oridion Medical 1987 Ltd., Jerusalem, Israel. Firm initiated recall is ongoing.
PRODUCT:
a) Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical, Recall # Z-0177-2008;
b) Capnostream20 Monitor with Masimor Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical, Recall # Z-0178-2008
REASON: Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.

MANUFACTURER: Edwards Lifesciences, Llc, Irvine, CA, by letter dated March 15, 2007. Firm initiated recall is complete.
PRODUCT: Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM stent, 80 CM Delivery System, Recall # Z-0179-2008
REASON: Failure to deploy.

MANUFACTURER: Recalling Firm: Teleflex Medical, Durham, NC, letter on/about November 1/2007. Manufacturer: Rai Wenzier Gmbh, Balgheim, Germany, Federal Republic of. Firm initiated recall is ongoing.
PRODUCT:
a) Pilling® Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL), Recall # Z-0266-2008;
b) Pilling® Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog Number: 505039, Non Sterile, Rx Only, (30 CM), Recall # Z-0267-2008;
c) Pilling® Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws,Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Recall # Z-0268-2008
REASON: The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage to surrounding tissue.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Knoxville, TN, by letter dated June 15, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Siemens ECAT ACCEL, Catalog No. 3545584, PET/CT Scanner, Recall # Z-0269-2008;
b) Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Recall # Z-0270-2008;
c) Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Recall # Z-0271-2008;
d) Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner, Recall # Z-0272-2008;
e) Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Recall # Z-0273-2008
REASON: Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.

MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated September 26, 2007. Manufacturer: Zimmer Gmbh, Winterthur, Switzerland. Firm initiated recall is ongoing.
PRODUCT: a) Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Recall # Z-0275-2008;
b) Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L;
Catalog No.: 01.00211.146, Recall # Z-0276-2008
REASON: Mislabeled as to size; 54mm package contains 46 mm device and vice versa.

MANUFACTURER: Wright Medical Technology, Inc., Arlington, TN, by letters on October 4, 2007. Firm initiated recall is ongoing.
PRODUCT: Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Recall # Z-0290-2008
REASON: Breakage. Breaking of the connecting foot that is on the distal surface of the instrument.

MANUFACTURER: Pioneer Surgical Technology, Marquette, MI, by letter dated October 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Recall # Z-0291-2008
REASON: The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.

MANUFACTURER: Recalling Firm: Toshiba America Medical Systems, Inc., Tustine, CA, by letters beginning on October 2, 2007. Manufacturer: Toshiba Corp. Medical Engineering Ctr., Nasu Works, Otawara-Shi, Tochigi, Japan. Firm initiated recall is ongoing.
PRODUCT: Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equipped with Digital Radiography System with Software version 3.4er000, Recall # Z-0293-2008
REASON: System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.

MANUFACTURER: Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, by letter on October 17, 2007. Manufacturer : Medtronic Navigation, Inc., Littleton, MA
PRODUCT: Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, (software version 3.0), Recall # Z-0294-2008
REASON: Reversed Instrument Position: a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)

MANUFACTURER: Xoran Technologies, Inc., Ann Arbor, MI, by visit between July 25, 2006 and August 10, 2007. Firm initiated recall is complete.
PRODUCT: Xoran MiniCAT for ENT. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging, Recall # Z-0296-2008
REASON: The hard drive may crash, resulting in loss of data from patient CT scans.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 28, 2007

CLASS I
MANUFACTURER: Thoratec Corp., Pleasanton, CA, by letter on October 19, 2007 and by press statement on November 7, 2007. Firm initiated recall is ongoing.
PRODUCT: Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001, Recall # Z-0212-2008
REASON: Pneumatic Leaks: air leaks developing in the pneumatic driveline when subjected to excessive stress at the junction of the percutaneous line to the pump housing due to sharp bending when implanted (paracorporeal-external-position).

CLASS II
MANUFACTURER: Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by WEB site posting on March 13, 2007 and by letter beginning on March 16, 2007.
Manufacturer: Boston Scientific Corporation CRM Ireland, Clomel, County Tipperary
Ireland. Firm initiated recall is ongoing.
PRODUCT:
a) Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872, Recall # Z-0047-2008;
b) Guidant VITALITY AVT, Models A135 and A155. Implantable Cardioverter Defibrillator, ICD. Atrial and Ventricular Therapies, Recall # Z-0048-2008;
c) Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillators (ICD). (This model is not available in the USA), Recall # Z-0049-2008;
d) Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter
Defibrillators (ICD). Recall # Z-0050-2008;
e) Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Recall # Z-0051-2008;
f) Guidant CONTAK RENEWAL 3 (Models H170, H173, H175), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Guidant CONTAK RENEWAL 4 (Models H190,H195) *, Guidant CONTAK RENEWAL 4 HE (Models H197, H199)* Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. (* models are not available in the USA), Recall # Z-0052-2008;
g) Guidant CONTAK RENEWAL 3 AVT (Models M150, M155) Guidant CONTAK RENEWAL 3 AVT HE (Models M157, M159), Guidant CONTAK RENEWAL 4 AVT (Models M170, M175)*, Guidant CONTAK RENEWAL 4 AVT HE (Models M177 and M179)*. Cardiac Resynchronization Therapy Defibrillator (CRT-D). (* models are not available in the USA), Recall # Z-0053-2008;
REASON: Erroneous Display/Atypical Charge Time Behavior: 1)-End of Life (EOL) or Elective Replacement Indicator (ERI) is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2) Extended ERI charge time limits: Charge times during mid-life may remain below a normal extension of the ERI charge time .

MANUFACTURER: Electric Mobility Corp., Sewell, NJ, by letter on October 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an Electric Seat Lift Actuator or a Seat Post to attach the seat to the vehicle; Model Number(s) 300F, 600C, 600T, and 600F, Recall # Z-0174-2008
REASON: Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from the vehicle; 3) Models using Seat-On Lifting brackets with a hoist to raise an EMC vehicle equipped with a Seat Lift, seat may not fully retract because of incorrect Seat-On Lift bracket Installation.

MANUFACTURER: Electric Mobility Corp., Sewell, NJ, by letter on May 29, 2007. Firm initiated recall is ongoing.
PRODUCT: Rascal Scooters with Electric seat lifts, Model 600 Series, distributed between 10/27/2005 - 3/31/2006, Recall # Z-0175-2008
REASON: Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from the vehicle; 3) Models using Seat-On Lifting brackets with a hoist to raise an EMC vehicle equipped with a Seat Lift, seat may not fully retract because of incorrect Seat-On Lift bracket Installation.

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on November 9, 2007. Firm initiated recall is ongoing.
PRODUCT: Philips, Voxel Q workstations, utilizing AcQSim or AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 and any Mx8000, Mx8001DT, or Brilliance 6, 10, 16, 16P, and Big Bore CT systems connected to the VoxelQ, Recall # Z-0180-2008
REASON: Incorrect simulation and/or beam placement: An anomaly has been identified with the Philips VoxelQ workstation utilizing AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 when computing absolute patient marking coordinates with data containing reconstruction offsets from the Mx800, the Mx8001DT, and the Brilliance 6, 10, 16, 16P, and Big Bore CT systems. When data from these systems contain reconstruction offsets, the absolute marking coordinates computed within Virtual Fluoroscopy package can be incorrect. Absolute patient marking coordinates computed on data without any reconstruction offsets are correct.

MANUFACTURER: Applied Biotech, Inc., San Diego, CA, by letter on September 28, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Clearview, hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Recall # Z-0244-2008;
b) Clearview hCG Combo Waived for urine & Moderate for serum, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Recall # Z-0245-2008
REASON: Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity; therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated September 18, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/Ref 141232, Recall # Z-0255-2008
REASON: Mislabeled as to size. The package actually contained a 71 mm tray.

MANUFACTURER: Recalling Firm: Abbott Laboratories, Inc., Irving, TX, by letter on November 10, 2007. Manufacturer: Inpeco Spa, Segrate, Italy. Firm initiated recall is ongoing.
PRODUCT: Abbott Accelerator APS System Input/Output Module (IOM); List Number: 7L01-01, Recall # Z-0257-2008
REASON: Sample problems. Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlier, which may result in Sample ID mis-association, sample contamination and/or a sample being reprocessed to remain on the Priority Output Lane without any associated tests downloaded for reprocessing. The other two conditions are related to Sample Identification (SID) usage and lower case alpha characters and APS work cell configuration.

MANUFACTURER: Recalling Firm: Baxter Bioscience, Westlake Village, CA, by letter dated October 24, 2007. Manufacturer: Baxter Healthcare Corporation Medication Delivery Division, Irvine, CA. Firm initiated recall is ongoing.
PRODUCT: Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Recall # Z-0263-2008
REASON: Sterility (package integrity) compromised: This recall is being conducted due to incomplete seal of the product package at the corner of the outer tray and tyvek lid.

MANUFACTURER: Recalling Firm: B. Braun Interventional Systems, Plymouth, MN, by letter on October 10, 2007. Manufacturer: B. Braun Celsa Medical, Chasseneuil, France. Firm initiated recall is ongoing.
PRODUCT: Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP.. (The VenaTech LP vena cava filter is pre-loaded in a syringe (cartridge) and provided as a system with introducer accessories and instructions to accommodate delivery and implantation either via the femoral or jugular approach.), Recall # Z-0264-2008
REASON: Sterility (package integrity) compromised. Package sealing problem leaving packaging partially open on one of the four sealed Tyvek pouch edges.

MANUFACTURER: Recalling Firm: Abbott Laboratories Inc., South Pasadena, CA, by letter on August 10, 2007. Manufacturer: Thermo Fisher Microgenics, Fremont, CA. Firm initiated recall is ongoing.
PRODUCT: Abbott Clinical Chemistry Aeroset/Architect (c Systems) Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Recall # Z-0288-2008
REASON: Incorrect Calibrator values. Changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard.

MANUFACTURER: Metrika, Inc., Sunnyvale, CA, by letter on September 14, 2007. Firm initiated recall is ongoing.
PRODUCT: A1CNOW+ with sampler 10-Test Kits (Product No: 3022), (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used by professional healthcare providers to monitor long-term glycemic control in people with diabetes. The product is sold as a kit with a disposable monitor and reagents for ten A1C tests and is suitable for use at the point-of-care, Recall # Z-0289-2008
REASON: Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit.

CLASS III
MANUFACTURER: Bio-Rad Laboratories, Inc., Hercules, CA, by telephone and fax on September 25, 2007. Firm initiated recall is ongoing.
PRODUCT: BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD, Recall # Z-0256-2008
REASON: Mislabeling. Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive).

MANUFACTURER: Recalling Firm: Boston Scientific Target, Fremont, CA, by letter dated July11, 2007. Manufacturer: Boston Scientific Corp-Plymouth Tech. Center, Plymouth, MN. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number: 10042, Made in USA, Recall # Z-0259-2008;
b) Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: Recall # Z-0260-2008
REASON: Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 21, 2007

CLASS II
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters dated August 20 and August 23, 2007.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
PRODUCT:
a) Philips Medical System - BV Pulsera Mobil C-arms with Remote Control Option, Recall # Z-0059-2008;
b) Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option, Recall # Z-0060-2008
REASON: System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.

MANUFACTURER: Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by letter on July 13, 2007 and July 23, 2007. Manufacturer: Depuy CMW, Blackpool, Lancashire, UK. Firm initiated recall is ongoing.
PRODUCT: SmartSeal Wedge Femoral Pressurizer; Product Code/Catalog No: 3206002. This product allows for effective and controlled pressurization of bone cement into the femur and the acetabulum during hip arthroplasty procedures, Recall # Z-0176-2008
REASON: Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City UT, by letter dated October 11, 2007. Firm initiated recall is ongoing.
PRODUCT: GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems, Recall # Z-0181-2008
REASON: Tracking Accuracy - Image intensifier supplier's change on the C-Arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.MANUFACTURER: Pacific Bioscience Lab, Inc., Bellevue, WA, by press release and its Website on August 30, 2007, Firm initiated recall is ongoing.

PRODUCT: Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Recall # Z-0182-2008
REASON: Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter dated October 11, 2007. Firm initiated recall is ongoing.
PRODUCT: Product Description : GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, Recall # Z-0183-2008
REASON: Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 27, 2007. Manufacturer: Stryker Trauma GmbH, Schonkirchen, Germany. Firm initiated recall is ongoing.
PRODUCT: Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Recall # Z-0214-2008
REASON: Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.

MANUFACTURER: Recalling Firm: SKF USA Inc., Norristown, PA, by letter on or about July 24, 2007. Manufacturer: Magnetic Elektromotoren, Liestal, Switzerland. Firm initiated recall is ongoing.
PRODUCT:
a) Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, Recall # Z-0215-2008;
b) Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, Recall # Z-0216-2008;
c) Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000,Recall # Z-0217-2008
REASON: Sudden failure of the actuator during lifting operation.

MANUFACTURER: Stryker Medical Div. of Stryker Corporation, Portage MI, by letter dated September 24, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Stryker Zoom (Atlas) powered patient transport stretcher, Model 660, Recall # Z-0219-2008;
b) Stryker Transport wheeled stretcher, Model 720, Recall # Z-0220-2008;
c) Stryker Transport wheeled stretcher, Model 721, Recall # Z-0221-2008;
d) Stryker OEM wheeled stretcher, Model 722, Recall # Z-0222-2008;
e) Stryker Transport wheeled stretcher, Model 735 (ST104), Recall # Z-0223-2008;
f) Stryker Advantage Series Emergency Care wheeled stretcher, Model 1001,Recall # Z-0224-2008;
g) Stryker Trauma wheeled stretcher, Model 1002, Recall # Z-0225-2008;
h) Stryker M-Series wheeled stretcher, Model 1005 (SM104), Recall # Z-0226-2008;
i) Stryker Advantage Series Emergency Care wheeled stretcher, Model 1009, Recall # Z-0227-2008;
j) Stryker M-Series wheeled stretcher, Model 1015 (SM204), Recall # Z-0228-2008;
k) Stryker Trauma wheeled stretcher, Model 1020, Recall # Z-0229-2008;
l) Stryker M-series powered patient transport stretcher, Model 1025 (SM304), Recall # Z-0230-2008;
m) Stryker Eye Surgery (Head/Neck Surgery) wheeled stretcher, Model 1069, Recall # Z-0231-2008;
n) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1210, Recall # Z-0232-2008;
o) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1211, Recall # Z-0233-2008;
p) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1231, Recall # Z-0234-2008;
q) Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1501, Recall # Z-0235-2008;
r) Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1509, Recall # Z-0236-2008;
s) Stryker Renaissance Series PACU wheeled stretcher, Model 1710, Recall # Z-0237-2008;
t) Stryker Renaissance Series PACU wheeled stretcher, Model 1711, Recall # Z-0238-2008;
u) Stryker Renaissance Series PACU wheeled stretcher, Model 1731,Recall # Z-0239-2008
REASON: The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated November 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Recall # Z-0240-2008
REASON: False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the side rail being able to be lowered without pulling on the release handle.

CLASS III
MANUFACTURER: Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters on August 29, 2007. Manufacturer: Matsushita Electric Industrial Co., Ltd. - Med. Sys. Division, Yokohama City, Kanagawa, Japan. Firm initiated recall is ongoing.
PRODUCT:
a) NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B,V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Recall $ Z-0253-2008;
b) NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0, Recall # Z-0254-2008
REASON: Multiple problems including: (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 14, 2007:

CLASS I
MANUFACTURER: Welch Allyn Protocol, Inc, Beaverton, OR, by letter dated October 26, 2007, and by press release on October 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E; Recall # Z-0129-2008
REASON: Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient.

CLASS II
MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta, PR, by letter on July 20, 2007. Firm initiated recall is ongoing.
PRODUCT: Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphates Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution., Recall # Z-0064-2008
REASON: Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concentration, is reported for the patient sample.

MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by visit on August 2007. Manufacturer: Suinsa, Madrid, Spain. Firm initiated recall is ongoing.
PRODUCT: Sunisa Flexi-DT S0014115 Digital Table Flexi-DT, 115-240 V // Internal Battery 24V, 4-2A Internal Battery 8A, 50-60Hz. Model Numbers 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, Recall # Z-0075-2008
REASON: Suinsa Flex-DT Table - Reports of several problems including: 1) Hot Brake (Longitudinal Overheating) potential risk of burns 2) Brake Locks and Sudden Releases 3) Emergency Stop Circuit Button; open instead of closed 4) Longitudinal Brakes Release does not engage properly 5) Tilting Movement causing tabletop to slide; may cause risk of pinched fingers to patient and/or operator 6) Lodging Pins on floor Uncovered; may cause potential risk of falling to patient and/or operator.

MANUFACTURER: Encore Medical, Lp, Austin, TX, by telephone, e-mail and letters beginning on August 2, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Foundation® Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; Recall # Z-0082-2008;
b) Foundation® Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant; Recall # Z-0083-2008;
c) Foundation® Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; Recall Z-0084-2008;
d) Foundation® Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; Recall # Z-0085-2008;
e) Foundation® Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; Recall # Z-0086-2008;
f) Foundation® Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; Recall # Z-0087-2008;
g) Foundation® Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; Recall # Z-0088-2008;
h) Foundation® Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant; Recall # Z-0089-2008;
i) Foundation® Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048;Sterile; assembly required by physician prior to implant; Recall # Z-0090-2008;
j) Foundation® Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; Recall # Z-0091-2008;
k) Foundation® Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050;Sterile; assembly required by physician prior to implant; Recall # Z-0092-2008;
l) Foundation® Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant; Recall # Z-0093-2008;
m) Foundation® Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; sterile; assembly required by physician prior to implant; Recall # Z-0094-2008;
n) Foundation® Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant; Recall # Z-0095-2008;
o) Foundation® Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly required by physician prior to implant; Recall # Z-0096-2008;
p) Foundation® Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; Recall # Z-0097-2008;
q) Foundation® Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; Recall # Z-0098-2008;
r) Foundation® Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly required by physician prior to implant; Recall # Z-0099-2008
REASON: Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.

MANUFACTURER: Recalling Firm: Smiths Medical ASD, Inc., Keene, NH, by letter on September 18, 2007. Manufacturer: Smiths Medical, Kent, UK. Firm initiated recall is ongoing.
PRODUCT: Portex perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090, Recall # Z-0100-2008
REASON: Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.

MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatosa, WI, by letters on July 15, 2007. Manufacturer: GE Medical Systems, Kretztechnik GmbH & Co. OHG, Zipf, Austria. Firm initiated recall is ongoing.
PRODUCT: GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; Recall # Z-0113-2008
REASON: When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.

MANUFACTURER: Recalling Firm: Warsaw Orthopedic, Inc. dba Medtronic Sofamor Danek, Warsaw, IN, by letter dated September 4, 2007. Manufacturer: Zinnanti Surgical Design LLC, Hershey, PA. Firm initiated recall is ongoing.
PRODUCT: Medtronic Sofamor Danek METRx ™ System Bayonet Electrosurgical Pencil, sterile; REF (P/N) 9560575; Recall # Z-0114-2008
REASON: Packaging weakness may compromise sterility and instructions for use are inadequate.

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters on October 1, 2007. Firm initiated recall is ongoing.
PRODUCT: The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application. All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is included on Brilliance CT Big Bore Scanners, Model Number 728243; Recall # Z-0121-2008
REASON: The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing.

MANUFACTURER: Recalling Firm: Karl Storz Endoscopy America, Inc., Culver City, CA, by letter on September 10, 2007. Manufacturer: Mpe, Inc., Milwaukee, WI. Firm initiated recall is ongoing.
PRODUCT: Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product number: 26601EQ-KT, Recall # Z-0144-2008
REASON: Outflow Difference. The accuracy of the equipment displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 26, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Mevatron KD2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 1940753; Recall # Z-0155-2008;
b) Mevatron KD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 8515520 and 9822685; Recall # Z-0156-2008;
c) Mevatron KDS,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401522; Recall # Z-0157-2008;
d) Mevatron KDS-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 9411588 and 9822693; Recall # Z-0158-2008;
e) Mevatron-2 6300, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401316; Recall # Z-0159-2008;
f) Mevatron M-2 6700,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401407; Recall # Z-0160-2008;
g) Mevatron M-2 6740, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401506; Recall # Z-0161-2008;
h) Mevatron MD-2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401654; Recall # Z-0162-2008;
i) Mevatron MDX-2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401746; Recall # Z-0163-2008;
j) Oncor Avant Garde, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 5863472; Recall # Z-0164-2008;
k) Oncor Expression,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 7360204 and 7360717; Recall # Z-0165-2008;
l) Oncor Impression Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),Model Number: 5857912; Recall # Z-0166-2008;
m) Oncor Impression, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 5857920; Recall # Z-0167-2008;
n) Mevatron M2/Primus Mid, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number 1940035,; Recall # Z-0168-2008;
o) Primus Plus, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 4504200; Recall # Z-0169-2008
REASON: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode.

MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha WI, by field service visits in December 2006. Manufacturer: GE Hangwei Medical Systems Co., LTD, Beijing PR, China. Firm initiated recall is complete.
PRODUCT: Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8; Recall # Z-0170-2008
REASON: Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.

MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by letter on June 25, 2007. Firm initiated recall is ongoing.
PRODUCT: Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems, Recall # Z-0213-2008
REASON: Unexpected loss of Treatment Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.

MANUFACTURER: Recalling Firm: Cardinal Health 303 Inc., dba Alaris Products, San Diego, CA, by letters on August 30, 2007. Manufacturer: Cardinal Health 303, Inc., Creedmoor, NC. Firm initiated recall is ongoing.
PRODUCT: Texium Closed Male Luer (CML), Model Number: 10012241, Recall # Z-0218-2008
REASON: Leaks. There is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue).

MANUFACTURER: OPTI Medical Systems, Inc., Roswell, GA, by e-mail and fax on/about July 18, 2007. Firm initiated recall is ongoing.
PRODUCT: OPTI® LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, Recall # Z-0119-2008
REASON: Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.

CLASS III

MANUFACTURER: Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Minneapolis, MN, by letter on August 27, 2007. Manufacturer: Medtronic Paceart, Arden Hills, MN. Firm initiated recall is ongoing.
PRODUCT: Medtronic Paceart System, 2006 Edition, The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices; Recall # Recall Number : Z-0081-2008
REASON: An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting no episodes have occurred, instead of indicating that no data is available.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 7, 2007:

CLASS II
MANUFACTURER: Recalling Firm: Bio-Logic Systems Corp., Mundelein, IL, by letters dated July 26, 2007. Manufacturer: TLK Industries Inc., Palatine, IL. Firm initiated recall is ongoing.
PRODUCT: Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video, Recall Z-0001-2008
REASON: Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.

MANUFACTURER: Medtronic, Inc., Danvers, MA, by letter dated August 29, 2007. Firm initiated recall is ongoing.
PRODUCT: Medtronic Export XT Aspiration Catheter, 6F Model Numbers: G146200USB (US Distribution) G1452006B (Outside US), Recall # Z-0063-2008
REASON: Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by telephone on or about July 24, 2007 and letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT:
a) Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)-- Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Recall # Z-0076-2008;
b) Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116, Recall # Z-0077-2008
REASON: Incorrect Product -- Mislabeled as to size. An 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.

MANUFACTURER: Gambro BCT, Inc., Lakewood, CO, by telephone beginning September 17, 2007 and letters on September 22, 2007. Firm initiated recall is ongoing.
PRODUCT: Spectra Optia apheresis system, a blood component separator. Part No. 61000, Recall # Z-0078-2008
REASON: Under specific conditions, apheresis machine could return up to 60 mL. of air to the patient.

MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on May 9, 2007 and November 1, 2007. Firm initiated recall is complete.
PRODUCT: ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612, Recall # Z-0080-2008
REASON: The plasma spray may delaminate from the proximal portion of the humeral stem.

MANUFACTURER: Recalling Firm: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated May 25, 2007. Manufacturer: Philips Medical Systems Technolo, Haifa, Israel. Firm initiated recall is ongoing.
PRODUCT: a) Brilliance CT Systems, 40 slice configuration. Computed tomography scanner, Model No. 728231, Recall # Z-0110-2008;b) Brilliance CT Systems 64 slice configuration. Computed tomography scanner. Model No. 728235, Recall # Z-0111-2008
REASON: Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis.

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Marlborough, MA, by letter on August 28, 2007. Manufacturer: Boston Scientific Corporation, Global Park, Heredia,Costa Rica. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 UPN Number: M00513321 REF: 1332-20, Recall # Z-0116-2008;
b) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 20 UPN Number: M00513331 REF: 1333-20, Recall # Z-0117-2008;
c) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40, Recall # Z-0118-2008;
REASON: Device lacked manufacturing finishing process resulting in scope damage.

CLASS III
PRODUCT: Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, Recall # Z-0065-2008
MANUFACTURER: Bio-Rad Laboratories, Redmond, WA, by letters on September 5, 2007 and September 19, 2007. Firm initiated recall is complete.
REASON: Incorrect Instructions. The packages insert states to add 100L of conjugate; it should state to add 100uL.

MANUFACTURER: Recalling Firm: Olympus America Inc., Center Valley, PA, by letter dated September 20, 2007. Manufacturer: Aomori Olympus Co Ltd, Aomori, Japan. Firm initiated recall is ongoing.
PRODUCT:
a) Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Recall # Z-0105-2008;
b) Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30, Recall # Z-0106-2008;
c) Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Recall # Z-0107-2008;
d) Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Recall # Z-0108-2008
REASON: Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath.

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Marlborough, MA, by letter dated September 10, 2007. Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303, Recall # Z-0109-2008
REASON: Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.

MANUFACTURER: EMD Chemicals, Inc., Gibbstown, NJ, by letter dated July 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; Item # 660/75 1 liter and Item 660/85 /4 liter poly bottles, Recall # Z-0133-2008
REASON: Batch Out of Specifications. The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 31, 2007

CLASS I
MANUFACTURER: Recalling Firm: Medtronic, Inc., Rhythm Management, Minneapolis, MN, by press release, FDA Statement and letter dated October 15, 2007.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0067-2008;
b) Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0068-2008;
c) Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0069-2008;
d) Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0070-2008
REASON: Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and the President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis. This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output.

CLASS II
MANUFACTURER: Recalling Firm: Smith and Nephew, Inc., Memphis, TN, by telephone on July 12, 20007 and letter dated July 24, 2007. Manufacturer: Finsbury Orthopaedics, Leatherhead, UK. Firm initiated recall is ongoing.
PRODUCT:
a) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component, Recall # Z-0017-2008
b) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. Hip implant component, Recall # Z-0018-2008
c) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant component, Recall # Z-0019-2008;
d) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component, Recall # Z-0020-2008;
e) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant component, Recall # Z-0021-2008;
f) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component, Recall # Z-0022-2008;
g) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component, Recall # Z-0023-2008;
h) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component, Recall # Z-0024-2008;
i) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant component, Recall # Z-0025-2008;
j) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component, Recall # Z-0026-2008;
k) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component, Recall # Z-0027-2008;
l) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component, Recall # Z-0028-2008;
m) Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component, Recall # Z-0029-2008;
n) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component, Recall # Z-0030-2008;
o) Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. Hip implant component, Recall # Z-0031-2008;
p) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component, Recall # Z-0032-2008;
q) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component, Recall # Z-0033-2008
REASON: The carton label may not reflect the correct size of the Acetabular cup.

MANUFACTURER: Remington Medical, Inc., Alpharetta, GA, by letter dated July 23, 2007. Firm initiated recall is ongoing.
PRODUCT: Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Recall # Z-0058-2008
REASON: Sterility, inadequate -- Pathway may not be sterile as labeled.

MANUFACTURER: Philips, Medical Systems, Andover, MA, by letter dated September 4, 2007. Firm initiated recall is ongoing.
PRODUCT: HeartStart XL Defibrillator/Monitor, Model: M4735A, Recall # Z-0062-2008
REASON: Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.

MANUFACTURER: Becton Dickinson and Company, Waltham, MA, by letter dated August 9, 2007. Firm initiated recall is complete.
PRODUCT: BD Microkeratome K3000 and K4000; Catalog Number: 378660, Recall # Z-0066-2008
REASON: Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea.

MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on August 30, 2007. Firm initiated recall is ongoing.
PRODUCT: a) Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Sterile, Made in USA, Recall # Z-0072-2008; b) HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole
Plug; Hip prosthesis component. Sterile; made in USA, Recall # Z-0073-2008
REASON: Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

MANUFACTURER: Steris Corporation Hopkins Facility, Mentor, OH, by telephone on September 12, 2007, and by letters on September 28, 2007. Firm initiated recall is ongoing.
PRODUCT: Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port of the endoscope., Recall # Z-0101-2008
REASON: Loose or missing adaptor. The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor’s housing. The absence of adaptor #6’s center insert may affect the sterilization process of the attached endoscope.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by telephone on August 9, 2007 and by letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Orthopedics Apical Hole Plug, 3/8 – 24 threaded, TI-6AL-4V alloy, sterile; REF123741, Recall # Z-0102-2008
REASON: Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.

MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove, MN, by telephone, interoffice memo and letter on September 11, 2007. Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C, Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile EO, Recall # Z-0103-2008;
b) Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico, Recall # Z-0104-2008
REASON: Missing holes: Catheters are missing the catheter's side holes.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
MANUFACTURER: Recalling Firm: Medtronic, Inc., Rhythm Management, Minneapolis, MN, by press release, FDA Statement and letter dated October 15, 2007.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0067-2008;
b) Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0068-2008;
c) Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0069-2008;
d) Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0070-2008
REASON: Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of Medicine, Director of Cardiac Electrophysiology, Washington University School of Medicine and the President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis. This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 24, 2007

CLASS II
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on February 22, 2007, Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
PRODUCT: FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. Recall # Z-0002-2008
REASON: Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter, on or about September 28, 2007. Manufacturer: Becton Dickinson Caribe Ltd, San Lorenzo, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems. Catalog Number 366356, Recall # Z-0044-2008;
b) Microtainer Safety Flow Lancets; Yellow Sterile Use once and discard; 2.2mm Blade Length; 1.0mm blade width; Becton Dickinson Vacutainer System.Catalog number 365759, Recall # Z-0045-2008;
c) Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Blade Width; Becton Dickinson Vacutainer Systems, Catalog number 366357, Recall # Z-0046-2008
REASON: Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.

CLASS III
MANUFACTURER: Esa Biosciences, Inc., Chelmsford, MA, by telephone and letter on September 20, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762, Recall # Z-0042-2008;
b) ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142, Recall # Z-0043-2008
REASON: Level 1 and Level 2 Control values were incorrectly assigned.

MANUFACTURER: Zoll Lifecor Corporation, Pittsburgh, PA, by letters on September 14, 2007. Firm initiated recall is ongoing.
PRODUCT: Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA). Product number 10A0894-A01. Recall # Z-0061-2008
REASON: Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 17, 2007

CLASS II
MANUFACTURER: Encore Medical, Lp, Austin, TX, by letter on August 9, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) EPIK® KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument, Recall # Z-0009-2008;
b) EPIK® KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument, Recall # Z-0010-2008
REASON: Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.

MANUFACTURER: Pml Microbiologicals, Inc., Wilsonville, OR, by telephone and fax on August 17, 2007. Firm initiated recall is ongoing.
PRODUCT: Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates. PML's catalog #P1174, Recall # Z-0011-2008
REASON: Marketed a regulated product without a 510(k).

MANUFACTURER: Pml Microbiologicals, Inc., Wilsonville, OR, by telephone and fax on April 23, 2007. Firm initiated recall is ongoing.
PRODUCT: Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML for screening for Vancomycin Resistant Enterococc, Catalog #P1174, Recall # Z-0014-2008
REASON: Plates manufactured without vancomycin. Possibility for false resistant results.

MANUFACTURER: Medtronic Neurological, Minneapolis, MN, by letter beginning on July 11, 2007. Firm initiated recall is ongoing.
PRODUCT: Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinican Programmer Model 8840. Implantable Neurostimulator for Urinary Control. Catalog # 8870MM01 & 8870NNB01, Recall # Z-0037-2008
REASON: A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant.

MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by telephone call or service representative visit beginning July 18, 2007. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
PRODUCT: Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers, Recall # Z-0038-2008:
REASON: Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use.

MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letters on July 30, 2007. Manufacturer: Diagnostica Stago - Taverny Site, Taverny, France. Firm initiated recall is ongoing.
PRODUCT: STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic, Recall # Z-0039-2008
REASON: Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.

MANUFACTURER: Medtronic Neurological, Minneapolis, MN, by letters beginning on July 11, 2007. Firm initiated recall is ongoing.
PRODUCT: Medtronic InterStim INS (Model 3023) with N’Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N’Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control, Recall # Z-0040-2007-8
REASON: Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N’Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

MANUFACTURER: Advanced Bionics Corp., Sylmar, CA, by visit on August 3, 2007. Firm initiated recall is complete.
PRODUCT: Precision Implantable Pulse Generator (IPG), Model Number SC-110, Recall # Z-0055-2008
REASON: Mislabeled. Product labeled with the incorrect shelf-life information.

MANUFACTURER: Mallinckrodt Inc., Cincinnati, OH, by letter on September 20, 2007. Firm initiated recall is ongoing.
PRODUCT: Angiomat Illumena Injector with Auxiliary Console, , Recall # Z-0056-2008
REASON: Synchronization problems. Units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit’s main console and the unit’s auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection delivered to the patient.

MANUFACTURER: I-Flow Corporation, Lake Forest, CA, by letter on March 27, 2007. Firm initiated recall is complete.
PRODUCT: ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, anesthetic/ narcotic medication pump. Recall # Z-0057-2008
REASON: Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the the device to deliver continuously at 7 ml/hr instead of 2 ml/hr.

CLASS III
MANUFACTURER: Naviscan PET Systems, San Diego, CA, by telephone and letters on August 1 and 2, 2007 and August 16, 2007. Firm initiated recall is ongoing.
PRODUCT: PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging, Recall # Z-0041-2008
REASON: Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired on the PEMFIex product line. 1. The Positron Emission Mammography Standardized Uptake Value (PEMSUV) and distance measurements for the product mentioned above may be inaccurate if a zoomed image has been opened, measurement tools are used, and the applet remains open while subsequent measurements are being made on another applet (12 slice view). This software defect results in unreliable andlor inconsistent readings in the size, distance between lesions and mass measurement, which could result in the physician selecting inaccurate margins for surgery. 2. In addition, under these same circumstances the Region of Interest (ROI) numbering might not be sequential or multiple regions within the same image might have the same number. Duplicative numbering could result in confusion in definition of the region of interest. 3. When images, user defined as "Other," are acquired, the thumbnail image is mislabeled as "LCC" (Left Craniocaudal) while the caption contains the correct user-defined labeling. This thumbnail mislabeling could result in reader confusion in the body part being displayed.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 10, 2007

CLASS II
MANUFACTURER: Meretek Diagnostics, Inc., Lafayette, CO, by letter on May 2, 2007. Firm initiated recall is complete.
PRODUCT: BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic, Recall # Z-0003-2008
REASON: Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.

MANUFACTURER: Recalling Firm: Lemaitre Vascular, Inc., Burlington, MA, by “Advisory Notice" on July 18, 2007 and September 24, 2007. Manufacturer: Cardiovascular Innovations, Athens, TX. Firm initiated recall is ongoing.
PRODUCT: CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC), Recall # Z-0008-2008
REASON: Sterility of device may be compromised due to breach in sterile barrier.

MANUFACTURER: Abbott Spine, Austin , TX, by telephone on July 18, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-50, Recall # Z-0004-2008;
b) PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60, Recall # Z-0005-2008
REASON: Tip of PathFinder surgical instrument broke during procedure.

MANUFACTURER: Recalling Firm: Datex - Ohmeda, Inc., Madison, WI, by letter dated July 19, 2007. Manufacturer: Molecular Products, Ltd., Dunmow, United Kingdom. Firm initiated recall is ongoing.
PRODUCT: GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems, Recall # Z-0006-2008
REASON: Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module.

CLASS III
MANUFACTURER: Recalling Firm: Tosoh Bioscience Inc., Grove City, OH, by letter dated July 2, 2006. Manufacturer: Tosoh Corporation, Minato-Ku, Japan. Firm initiated recall is ongoing.
PRODUCT: 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic. Catalog # 020661, Recall # Z-0007-2008
REASON: Firm discovered that a deterioration value of approximately 20% was found when the product of this lot was measured. Tosoh AIA confirmed that deterioration of the product occurred over time and resulted in a deviation from the assigned value.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on August 10, 2007. Manufacturer: Becton Dickinson Medical Systems, Hancock, NY. Firm initiated recall is ongoing.
PRODUCT:
a) Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Reorder number 371111, Recall # Z-0012-2008;
b) Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place Product in a puncture resistant container and dispose properly. Reorder number 371211, Recall # Z-0013-2008
REASON: Complaints received of rust on the blades of BD Bard-Parker Surgical blades.

MANUFACTURER: Recalling Firm: Thermo Fisher Scientific, Pittsburgh, PA, by a Technical Bulletin dated July 24, 2007. Manufacturer: Thermo Fisher Scientific, Victoria, Australia. Firm initiated recall is ongoing.
PRODUCT: Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic, Recall # Z-0015-2008
REASON: Method is susceptible to positive interference from endogenous ALT in patient samples.

MANUFACTURER: Louisville Apl Diagnostics, Inc., Seabrook, TX, by FedEx on July 18, 2006. Firm initiated recall is complete.
PRODUCT: APhL® HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic, Recall # Z-0034-2008
REASON: Product mislabeled. Outer container labeled with incorrect lot number.

MANUFACTURER: Recalling Firm: Heraeus Kulzer Inc., Dental Products Division, South Bend, IN, by telephone or letter beginning on or about July 9, 2007.
Manufacturer: Heraeus Kulzer Gmbh & Co. KG (Medical Division), Wehrheim 1, Federal Republic of Germany. Firm initiated recall is ongoing.
PRODUCT:
a) Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent; Reorder No. 66001710, Recall # Z-0035-2008;
b) Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent; Reorder No. 6018222, Recall # Z-0036-2008
REASON: The material may solidify in the bottle, and thus be rendered unusable.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 3, 2007

CLASS I
MANUFACTURER: Baxa Corporation, Englewood, CO, by telephone and letter on June 27, 2007. Firm initiated recall is ongoing.
PRODUCT: Exacta-Mix 2400 OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Recall # Z-1238-2007
REASON: A software defect could allow up to 50mL of extra volume being added to a TPN (Total Parenteral Nutrition) solution.

CLASS II
MANUFACTURER: Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letters on November 3, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems, Recall # Z-0013-2007;
b) Brilliance (a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.Recall # Z-0014-2007
REASON: A potential anomaly was identified on the CT subsystem, which could result in the radiation dose being different than the calculated dose reported to the operator.

MANUFACTURER: Cardinal Health 301 LLC DBA Cardinal Health Pyxis Products, San Diego, CA, by telephone and letter beginning on August 13, 2007. Firm initiated recall is ongoing.
PRODUCT: Pyxis Anesthesia System 3500, Model 3500, Recall # Z-0555-2007
REASON: System lock up; mini-drawers -under certain circumstances during use, are not accessible, delaying the user from accessing critical medications.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on March 1, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) OEC 9900 Elite image-intensified fluoroscopic x-ray system, Recall # Z-0676-2007;
b) OEC 9800 image-intensified fluoroscopic x-ray system, Recall # Z-0677-2007;
c) OEC 8800 image-intensified fluoroscopic x-ray system, Recall # Z-0678-2007;
d) OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, Recall # Z-0679-2007;
e) OEC FluoroTrak 9800 PLUS, image-intensified fluoroscopic x-ray system, Recall # Z-0680-2007;
f) OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, Recall # Z-0681-2007;
g) OEC 9800 Plus (Flourotrak) Image-intensified fluoroscopic x-ray system, Recall # Z-0682-2007;
h) OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, Recall # Z-0683-2007
REASON: During routine service, primary and/or secondary collimators may not have been properly reinstalled.

MANUFACTURER: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters starting April 3, 2007 through April 9, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Practix 33 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations, Recall # Z-0762-2007;
b) Practix 160 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations, Recall # Z-0763-2007
c) Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations, Recall # Z-0764-2007
REASON: X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated July 9, 2007 and August 20, 2007. Firm initiated recall is ongoing.
PRODUCT
a) Philips Bucky Diagnost X-Ray System, Recall # Z-0907-2007;
b) Philips Digital Diagnost X-Ray system, Recall # Z-0908-2007;
c) Philips Easy Diagnost X-Ray System, Recall # Z-0909-2007;
d) Philips Easy Diagnost Eleva, Recall # Z-0910-2007;
e) Philips Omni Diagnost Eleva, Recall # Z-0911-2007;
f) Philips Multi Diagnost Eleva, Recall # Z-0912-2007
REASON: Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.

MANUFACTURER: General Electric Medical Systems, LLC, Waukesha, WI, by visit beginning on May 31, 2006. Firm initiated recall is complete.
PRODUCT: GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976, Recall # Z-1087-2007
REASON: Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.

MANUFACTURER: Recalling Firm: General Electric Medical Systems, LLC, Waukesha, WI, by visit beginning on June 6, 2006. Manufacturer: General Electric Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is complete.
PRODUCT: GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. Recall # Z-1088-2007
REASON: The systems do not contain a certification label on the C2 Cabinet (Beam-limiting control).

MANUFACTURER: K Tex, Galvez, LA, by letter dated November 3, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Laser Distance and Level Transmitters, Model No. LT4C, Recall # Z-1120-2007;
b) Laser Level Transmitters, Model No. LM4C, Recall # Z-1121-2007;
c) LaserTrak, Model No. LT80, Recall # Z-1122-2007;
d) Laser Meter, Model No. LTM80, Recall # Z-1123-2007;
e) Laser Distance and Level Transmitters, Model No. LT200, Recall # Z-1124-2007;
f) Laser Distance and Level Transmitters, Model No. LM200, Recall # Z-1125-2007;
g) Laser Distance and Level Transmitters, Model No. LM02, Recall # Z-1126-2007
REASON: Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports)

MANUFACTURER: Philips Nuclear Medicine, Inc., Fitchburg, WI, by letter on August 21, 2007. Firm initiated recall is ongoing.
PRODUCT: The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of a Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating system and software, and a UNIX terminal emulation package on a personal computer, which allows the user to enter patient data into the system, use that data to construct a plan for radiation therapy, and evaluate the plan- Philips Medical Systems-Model #9200-0652A-ENG, 9200-0700A-ENG, 9200-0700B-ENG, 9200-0700C-ENG (with software versions 7.6C, 8.0d and 8.0h), Recall # Z-1212-2007
REASON: Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction.

MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on August 2, 2007. Firm initiated recall is ongoing.
PRODUCT: Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics. Product numbers: 5537-G-109, 5537-G-111, 5537-G-113, 5537-G-116, 5537-G-119, 5537-G-122, 5537-G-125, 5537-G-128, 5537-G-131, 5537-G-209, 5537-G-211, 5537-G-213, 5537-G-216, 5537-G-219, 5537-G-222, 5537-G-225, 5537-G-228, 5537-G-231, 5537-G-309, 5537-G-311, 5537-G-313, 5537-G-316, 5537-G-319, 5537-G-322, 5537-G-325, 5537-G-328, 5537-G-331, 5537-G-409, 5537-G-411, 5537-G-413, 5537-G-416, 5537-G-419, 5537-G-422, 5537-G-425, 5537-G-428, 5537-G-431, 5537-G-509, 5537-G-511, 5537-G-513, 5537-G-516, 5537-G-519, 5537-G-522, 5537-G-525, 5537-G-528, 5537-G-531, 5537-G-609, 5537-G-611, 5537-G-613, 5537-G-616, 5537-G-619, 5537-G-622, 5537-G-625, 5537-G-628, 5537-G-631, 5537-G-709, 5537-G-711, 5537-G-713, 5537-G-716, 5537-G-719, 5537-G-722, 5537-G-725, 5537-G-728, 5537-G-731, 5537-G-809, 5537-G-811, 5537-G-813, 5537-G-816, 5537-G-819, 5537-G-822, 5537-G-825, 5537-G-828, 5537-G-831, Recall # Z-1231-2007
REASON: Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of the plastic post.

MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter on July 31, 2007 and by press release on September 14, 2007. Manufacturer: AM2PAT, Angier, NC. Firm initiated recall is ongoing.
PRODUCT:
a) Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton, Recall # Z-1235-2007;
b) Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton, Recall # Z-1236-2007
REASON: Particulate matter in product.

MANUFACTURER: Cerner Corp., Kansas City, MO, by telephone on August 23, 2007 and by letters dated August 29, 2007 and September 4, 2007. Firm initiated recall is complete.
PRODUCT: Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities Recall # Z-1243-2007
REASON: Defects in the Auto Launch functionality make it possible for a mismatch of patient data.

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by visit beginning on September 7, 2007. Firm initiated recall is ongoing.
PRODUCT: Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Recall # Z-1244-2007
REASON: Under certain circumstances, the product's software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual to clarify an icon not described in the previous User Manual.

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by visit beginning on September 12, 2007. Firm initiated recall is ongoing.
PRODUCT: daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system. Model number IS2000, part number 351040-04, Recall # Z-1245-2007
REASON: Product may malfunction and fail to start up on AC power.

MANUFACTURER: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letters on March 13, 2006. Firm initiated recall is complete.
PRODUCT: Trident PSL Acetabular Shell; Arc Deposited; Hydroxylapatite Coated; Cluster Screw Holes; Hip prosthesis component. Recall # Z-1261-2007
REASON: Dimensional anomaly.

MANUFACTURER: Merit Medical Systems, Inc, South Jordan, UT, by letter on August 22, 2007. Firm initiated recall is ongoing.
PRODUCT: Merit Medical Surgical Convenience Kits, Custom and SPPT,. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A, Recall # Z-1262-2007
REASON: Expiration Dating; Some Convenience Kits contain medications and/or skin preparations that may expire before the expiration date on the outer package label.

MANUFACTURER: Recalling Firm: Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on July 30, 2007. Manufacturer: Hitachi Medical Corporation, Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT: Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) body. A portion of the cable is referred to as the balun assembly or balun trap. The shoulder coil assembly is packaged in a cardboard box with foam inserts. Recall # Recall Number : Z-1263-2007
REASON: Overheating; A portion (balun assembly) of the cable that connects the shoulder coil to the actual MRI unit may malfunction and result in overheating of the balun assembly. The overheating of the balun assembly could result in injury to the patient or operator if either came into contact with the assembly.

MANUFACTURER: Spectrum Designs, Inc., Carpinteria, CA, by letters on July 24, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S, Recall # Z-1264-2007;
b) Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S; Recall # Z-1265-2007
REASON: Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant.

MANUFACTURER: Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Cranston, RI, by letter on July 16, 2007 and July 23,2007. Manufacturer: BARD SHANNON LIMITED, Humacao, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Davol Salute Fixation Reusable Handle Item Code: 0113024-Product Code 9113024 (Refurbished), Recall # Z-1266-2007;
b) Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished),
Recall # Z-1267-2007;
c) Davol Salute Reusable 18cm Shaft (Short/Open) Item Numbers: 0113037-Product Code: 9113037(Refurbished), Recall # Z- Z-1268-2007;
d) Davol Salute Laparoscopic 38cm Sterile Implant Cartridge, Sterile- 10 Q-ring;5/Box, Item Number: 0113058, Recall Number : Z-1269-2007
e) Davol Salute Laparoscopic 38cm Sterile Implant Cartridge, Sterile- 30 Q-ring;5/Box, Item Number: 0113035, Recall # Z-1270-2007;
f) Davol Salute Laparoscopic 38cm Sterile Implant Cartridge 60 Q-ring;5/Box, Item Number: 0113059, Recall # Z-1271-2007;
g) Davol Salute Short 18cm Sterile Implant Cartridge - 10 Q-ring;5/Box, Item Number: 0113043m, Recall # Z-1272-2007;
h) Davol Salute Short 18cm Sterile Implant Cartridge - 30 Q-ring;5/Box, Item Number: 0113061, Recall # Z-1273-2007
REASON: Malformed constructs (straight shots) may form causing injury to user/patient. Abdominal mesh attachment system component, for use in hernia repair.

CLASS III
MANUFACTURER: Abbott Laboratories Inc., South Pasadena, CA, by letter on April 04, 2007. Firm initiated recall is ongoing.
PRODUCT: Abbott Aeroset/Architect Clinical Chemistry, AST Activated (ASTA), List Number: 8D37-30, Recall # Z-1079-2007
REASON: Mislabeling: The empty cartridges supplied with Clinical Chemistry ASTA, lot number 46059HW00, have an incorrect top label. The top label on the cartridge incorrectly indicates ALTA instead of ASTA

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of September 26, 2007

CLASS I
MANUFACTURER: Recalling Firm: Welch Allyn Protocol, Inc., Beaverton, OR, by press release on August 23, 2007 and letters on August 29, 2007. Manufacturer: MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL. Firm initiated recall is ongoing.
PRODUCT: Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E), Recall # Z-1223-2007
REASON: Failure to deliver shock: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated August 15, 2007. Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
PRODUCT: Baxter Colleague CX Single Channel Volumetric Infusion Pumps; product code 2M8161, Recall # Z-1224-2007
REASON: Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.

CLASS II
MANUFACTURER: Stryker Medical Div. of Stryker Corporation, Portage, MI, by letter dated May 7, 2007. Firm initiated recall is ongoing.
PRODUCT: Stryker Medical – Wheeled Electric Stretcher, Model 1550, Recall # Z-1009-2007
REASON: The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists.

MANUFACTURER: Recalling Firm: Newport Medical Instruments Inc., Costa Mesa, CA, by Important Medical Correction letters on September 14, 2007.
Manufacturer: Flight Medical Ltd., Lod, Israel. Firm initiated recall is ongoing.
PRODUCT: Newport HT50 Ventilator (all Models), Recall # Z-1192-2007
REASON: Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not lasting as long as expected followed by ventilator shut down with less advance warning than when the battery was new.

MANUFACTURER: Humagen Fertility Diagnostics, Inc., Charlottesville, VA, by telephone and e-mail on May 7, 2007. Firm initiated recall is complete.
PRODUCT: IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL, Recall # Z-1220-2007
REASON: Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

MANUFACTURER: Biomet 3i, Palm Beach Gardens, FL, by e-mail and fax letter on August 3, 2007. Firm initiated recall is ongoing.
PRODUCT: LTX XP Miniplant, Dental Implant, Sterile, Model No. LTX3211 and Model No. LTX3213, Recall # Z-1221-2007
REASON:The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.

MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by letter dated July 6, 2007. Manufacturer: Bio-Rad Diagnostics Group, Irvine, CA. Firm initiated recall is ongoing.
PRODUCT: ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and 4 - 2 mL bottles of Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 containing prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers; list 6C27-05, Recall # Z-1222-2007
REASON: The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect iSystem Operations Manual.

MANUFACTURER: Nicolet Biomedical Div of Viasys Healthcare, Madison, WI, by letters on July 17, 2007. Firm initiated recall is ongoing.
PRODUCT: BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne, Recall # Z-1225-2007
REASON: The BMSI "MicroJack" patient interface electrode connection device used with the EEG monitor systems was found to be mis-wired. A complainant alleged that during depth electrode EEG study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on June 21, 2007. Manufacturer: BD Medical - Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.
PRODUCT: ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin, Catalog number 326743, Recall # Z-1226-2007
REASON: Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.

MANUFACTURER: Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letters dated August 1, 2007. Manufacturer: Medtronic Mexico, S. De R. L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
PRODUCT: Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag serves as the product sterile barrier, Recall # Z-1227-2007
REASON: Medtronic Custom Tubing Packs might have open header bag seals.

MANUFACTURER: Recalling Firm: NxStage Medical, Inc., Lawrence, MA, by letter, on August 24, 2007. Manufacturer: Medimexico, S. de R.L. de C.V., Tijuana, Mexico. Firm initiated recall is ongoing.
PRODUCT: NxStage Cartridge Express, CAR-170, for hemodialysis, Recall # Z-1228-2007
REASON: Potential for dialysate leaks from the cartridge during treatment.

MANUFACTURER: Bard Access Systems, Inc., Salt Lake City, UT, by letter on August 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Product Code 5583705, Recall # Z-1229-2007
REASON: Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.

MANUFACTURER: Stryker Spine, Allendale, NJ, by letters on July 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Stryker Radius Locking Caps, Catalog Number: 486610000, Recall # Z-1239-2007
REASON: Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod.

CLASS III

MANUFACTURER: Recalling Firm: Mentor Texas, Inc., Irving, TX, by letter on July 27, 2007. Manufacturer: Misonix, Inc., Farmingdale, NY. Firm initiated recall is ongoing.
PRODUCT: 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530, Recall # Z-1230-2007
REASON: Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number 5610-530.

MANUFACTURER: Diasorin, Inc., Stillwater, MN, by telephone and letter on August 21, 2007. Firm initiated recall is ongoing.
PRODUCT: 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E, Recall # Z-1237-2007
REASON: 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.

MANUFACTURER: Smiths Medical PM, Inc., Waukesha, WI, by letter on July 18, 2007. Firm initiated recall is ongoing.
PRODUCT: BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers: 340400, 3404001, and 3404002, Recall # Z-1240-2007
REASON: Phantom pacer spikes caused by a damaged resistor.

MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on October 17, 2006. Firm initiated recall is complete.
PRODUCT: Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325, Recall # Z-1241-2007
REASON: Loose fixation pegs: One lot of femoral components may have loose fixation pegs.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of September 19, 2007

CLASS II
MANUFACTURER: Abbott Laboratories, Inc., South Pasadena, CA, by letters on June 1, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Clinical Chemistry Lipase, in vitro diagnostic test reagent. List Numbers: 7D80-20 and 7D80-30, Recall # Z-1232-2007;
b) MULTIGENT Acetaminophen, in vitro diagnostic test reagent. List Number 2K99-20, Recall # Z-1233-2007
REASON: Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.

MANUFACTURER: Recalling Firm: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on September 4, 2007. Manufacturer: Teal Electronics Corp., San Diego, CA. Firm initiated recall is ongoing.
PRODUCT: The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, "Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL POWER SUPPLY UL *** Recall # Z-1234-2007
REASON: The TEAL Power Conditioning units may fail and result in the unit emitting fire and/or smoke. Note: the TEAL Power Conditioning Unit has the potential to fail when the scanner that is attached to the TEAL is powered and in use as well as when not in use.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of September 12, 2007

CLASS II

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on March 20, 2007. Manufacturer: BD Medical Systems Infusion Therapy, Nogales, Sonora, Mexico. Firm initiated recall is complete.
PRODUCT: BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile, Catalog # 368652, Recall # Z-0777-2007
REASON: The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.

MANUFACTURER: LifeScan, Inc., Milpitas, CA, by letter on April 23, 2007. Firm initiated recall is ongoing.
PRODUCT: OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems:
a)OneTouch Ultra,
b) OneTouch InDuo,
c) OneTouch Ultra2,
d) OneTouch UltraMini,
e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07 (100 pack), 020-244-07 (50 pack), 020-963-01(50 pack mail order)), Recall # Z-1042-2007
REASON: Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.

MANUFACTURER: Philips Medical Systems, Andover, MA, by letter dated July 2007. Firm initiated recall is ongoing.
PRODUCT: Intellivue Central Station Software for the: Intellivue Information Center, Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169, Recall # Z-1182-2007
REASON: Incorrect Patient Assignment: The information center will in most cases be associated with the “incorrect” patient.

MANUFACTURER: Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letters on September 1, 2007. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
PRODUCT: Kion Anesthesia Workstation, Article number: 6454800, Recall # Z-1203-2007
REASON: Overcharging of batteries and the release of acid fumes.

MANUFACTURER: Recalling Firm: Molnlycke Health Care, Inc., Norcross, GA, by letter on July 23, 2007 Manufacturer: Regent Hospital Products, Sdn Bhd, Kulim, Kedah Darulaman, Malaysia. Firm initiated recall is ongoing.
PRODUCT: Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8), Recall # Z-1219-2007
REASON: Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly.

CLASS III
MANUFACTURER: BioHorizons Implant Systems, Inc., Birmingham, AL, by letters and visit on March 12, 2007. Firm initiated recall is complete.
PRODUCT:
a) BioHorizons 0.035 Hex Driver, REF 300-377, non-sterile, Rx only, REF 300-377, Recall # Z-0692-2007;
b) BioHorizons 0.050 Hex Driver, Regular, REF 300-350, non-sterile, Rx only, Recall # Z-0693-2007;
c) BioHorizons 0.050 Hex Driver, Long, REF 300-351, non-sterile, Rx only, Recall # Z-0694-2007;
d) BioHorizons 0.050 Hex Driver, Regular, REF 134-350, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K, Recall # Z-1164-2007
REASON: Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.

MANUFACTURER: Avazzia, Inc., Dallas, TX, by letter on June 29, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Avazzia Tennant Biomodulator®; Model: BEST AV-1; P/N #TB04303-103, Recall # Z-1207-2007;
b) Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103, Recall # Z-1208-2007;
c) Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1; P/N #MB04182-103, Recall # Z-1208-2007;
d) Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103, Recall # Z-1210-2007
REASON: Plastic Cases may crack due to manufacturing by the supplier not meeting specifications.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of September 5, 2007

CLASS II
MANUFACTURER: Varian Medical Systems Inc, Palo Alto, CA, by letter on April 18, 2007. Firm initiated recall is ongoing.
PRODUCT: Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator, Recall # Z-1195-2007
REASON: Patient positioning errors may occur because of mechanical variations during product installation.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letter on August 16, 2007, and visit to follow. Firm initiated recall is ongoing.
PRODUCT:
a) Abbott CELL-DYN 3000 Hematology Analyzer, Model number
CELL-DYN 3000 CS: List Numbers 91323-01 and 91323-03,
CELL-DYN 3000 SL: List Numbers 91325-01 and 91325-03,
Recall # Z-1198-2007;
b) Abbott CELL-DYN 3500 Hematology Analyzer, Model number
CELL-DYN 3500 CS, List Numbers 91340-01 and 91340-03,
Model number CELL-DYN 3500 SL, List Numbers 91350-01 and 91350-03,
91350-01 1 EACH CD3500 SL ANALYZE(1 EACH) 1.000 0031192P,
91350-03 1 EACH CD3500SL ANAL-REF(1 EACH) 1.000 30336P96,
91350-03 1 EACH CD3500SL ANAL-REF 1.000 32159P96 05/05/2000,
91340-03 1 EACH CD 3300/3500CS(1 EACH) 1.000 30276N96 06/21/2000,
Recall # Z-1199-2007;
c) Abbott CELL-DYN 3700 Hematology Analyzer, Model number CELL-DYN 3700 CS, List Numbers 02H30-01and 91340-02, all serial numbers distributed on or before May 3, 2007. Model number CELL-DYN 3700 SL, List Numbers 02H31-01 and 02H31-03, all serial numbers distributed on or before May 3, 2007: 02H30-01 EA CD3700 CS(EA) 1.000 20222AN 01/16/2004 0708421226 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21423AK 04/16/2003 0705836717 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20575AK 01/17/2001 0700657123 ZINS 1024, 02H30-01 EA CD3700 CS(EA) 1.000 20088AN 11/14/2001 0701853939 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21086AK 04/02/2002 0702540521 ZINC 1024, 02H31-01 EA CD3700 SL 1.000 20158AK 01/20/2000 30001171534T2 NC 1024, 02H30-01 EA CD3700 CS 1.000 19966AN 03/17/2000 30003160556T2 NC 1024, 02H31-01 EA CD3700 SL 1.000 20210AK 02/15/2000 30002100642T2 NC 1024, 02H30-01 EA CD3700 CS(EA) 1.000 19999AN 11/20/2000 0700475941 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20333AK 05/30/2000 0700023564 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21162AK 05/29/2002 0702793182 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20662AK 10/09/2001 0701535236 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21151K 04/26/2002 0702654355 ZINC 1024, 02H31-01 EA CD3700 SL 1.000 20215AK 02/23/2000 30002110316T2 NC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/29/2000 0700519556 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/29/2000 0700519556 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21526AK 08/22/2003 0707048787 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21195AK 05/29/2002 0702793121 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21193AK 05/29/2002 0702759492 ZOR 1025, 02H30-01 EA CD3700 CS 1.000 19953AN 01/21/2000 39912022083U3 SALE 1025 02H30-01 EA CD3700 CS 1.000 19966AN 03/08/2000 30002101167U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20210AK 01/27/2000 39912213420U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20215AK 01/27/2000 39912212921U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20333AK 05/18/2000 30004103499U2 SALE 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20565AK 11/29/2000 0700519549 ZINS 1024, 02H30-01 EA CD3700 CS 1.000 19953AN 01/27/2000 30001270601T2 NC 1024, 02H30-01 EA CD3700 CS(EA) 1.000 19999AN 10/31/2000 0700430444 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20088AN 10/25/2001 0701722636 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20106AN 02/14/2002 0702285397 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/30/2000 0700531142 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20565AK 11/30/2000 0700531141 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20574AK 12/01/2000 0700419159 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20575AK 12/01/2000 0700419161 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20576AK 12/01/2000 0700419160 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20662AK 03/08/2001 0700818411 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21086AK 03/01/2002 0702067225 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21151AK 04/22/2002 0702638488 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21162AK 04/26/2002 0702536142 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21508AK 08/18/2003 0706963179 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22038AK 03/10/2005 0721127803 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22039AK 03/10/2005 0721127803 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22035AK 03/08/2005 0721102104 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22041AK 03/10/2005 0721127061 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20576AK 01/17/2001 0700657124 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20574AK 11/29/2001 0701921151 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 22055AK 03/22/2005 0721231650 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21836AK 08/26/2004 0710348806 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20368AK 06/15/2000 0700067140 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20369AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20370AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20371AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20372AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20373AK 06/21/2000 0700067141 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20340AK 05/26/2000 0700022704 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20344AK 05/30/2000 0700022198 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20347AK 05/26/2000 0700022704 ZOR 1025, 02H30-01 EA CD3700 CS(EA) 1.000 20010AN 10/11/2000 0700390326 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20036AN 02/27/2001 0700702499 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20037AN 02/28/2001 0700665110 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20039AN 03/08/2001 0700764419 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20059AN 05/23/2001 0701034352 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20069AN 07/13/2001 0701274789 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20073AN 07/25/2001 0701296466 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20075AN 07/25/2001 0701296466 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20117AK96 03/12/2004 0708902744 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20154AK96 08/28/2006 0724669259 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20200AN 07/01/2003 0706596666 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20201AN 07/01/2003 0706596666 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20233AN 02/17/2004 0708707057 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20465AK96 09/29/2006 0724957687 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20645AK 02/27/2001 0700702498 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20646AK 02/27/2001 0700702498 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20700AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20703AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20704AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20705AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20707AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20708AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20710AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20711AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20712AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20716AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20742AK 04/24/2001 0700847325 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20869AK 08/06/2001 0701363650 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20870AK 08/07/2001 0701326067 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20871AK 08/07/2001 0701326067 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20877AK 08/14/2001 0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20881AK 08/14/2001 0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20882AK 08/14/2001 0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20883AK 08/15/2001 0701428194 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20884AK 08/15/2001 0701428194 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20885AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20886AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20887AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20888AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20889AK 08/17/2001 0701419778 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20891AK 08/21/2001 0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20892AK 08/21/2001 0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20893AK 08/21/2001 0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20894AK 08/23/2001 0701458396 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20896AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20897AK 08/23/2001 0701458396 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20898AK 08/23/2001 0701439537 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20902AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20903AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20904AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20905AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20907AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20908AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20909AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20910AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20911AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20912AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20913AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20914AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20915AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20917AK 08/31/2001 0701419777 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20940AK96 03/08/2004 0708891681 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20967AK 10/19/2001 0701730439 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20970AK 10/19/2001 0701730439 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20987AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20989AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20991AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20992AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20993AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20994AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20996AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20997AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20998AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20999AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21000AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21001AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21002AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21003AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21004AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21005AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21045AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21046AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21048AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21049AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21050AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21058AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21059AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21060AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21061AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21062AK 02/08/2002 0702270892 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21063AK 02/11/2002 0702277975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21064AK 02/08/2002 0702270892 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21065AK 02/13/2002 0702282548 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21067AK 02/11/2002 0702277975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21068AK 02/13/2002 0702282548 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21069AK 02/15/2002 0702299928 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21070AK 02/19/2002 0702311964 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21076AK 02/26/2002 0702357048 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21082AK 02/28/2002 0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21083AK 02/28/2002 0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21084AK 02/28/2002 0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21089AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21090AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21091AK 03/08/2002 0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21092AK 03/08/2002 0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21093AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21094AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21095AK 03/08/2002 0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21096AK 03/12/2002 0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21097AK 03/12/2002 0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21098AK 03/13/2002 0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21099AK 03/12/2002 0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21100AK 03/14/2002 0702409791 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21101AK 03/13/2002 0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21102AK 03/13/2002 0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21103AK 03/19/2002 0702409792 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21104AK 03/14/2002 0702409791 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21105AK 03/19/2002 0702409792 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21107AK 03/19/2002 0702409792 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21127AK96 02/27/2004 0708817941 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21163AK 04/25/2002 0702452514 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21180AK 05/09/2002 0702726859 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21181AK 05/10/2002 0702726862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21182AK 05/09/2002 0702726859 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21183AK 05/10/2002 0702726862 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21244AK96 08/28/2006 0724669259 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21245AK96 08/17/2006 0724616503 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21473AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21474AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21475AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21476AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21478AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21479AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21480AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21481AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21482AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21483AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21485AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21590AK 11/20/2003 0707872598 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21592AK 11/20/2003 0707872598 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21624AK 01/21/2004 0708229861 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21625AK 01/21/2004 0708229861 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21627AK 01/26/2004 0708229862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21628AK 01/26/2004 0708229862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21629AK 01/26/2004 0708230220 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21630AK 01/27/2004 0708520940 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21639AK 02/05/2004 0708585282 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21640AK 02/05/2004 0708585282 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21643AK 02/10/2004 0708585283 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21644AK 02/