News Updates

  • Check out Industry News for Industry updates and Industry News.
    Click Here

  • Global Business Development Center Announced mdi Consultants Inc.
    to anchor turnkey solution  for companies building U.S. presence
    Read the Press Release


  • mdi's Alan Schwartz at press conference with the El Salvador Minister of Economy
    To learn more about the mdi Consultants, Inc.
    Seminar in El Salvador
    Click Here


  • mdi Consultants Inc. and LOK-RUS
    are pleased to announce strategic alliance!
    Click here for details

  • Help  Create the  
    FDA Staff

    Information Database
    by Clicking Here


  • Alan P. Schwartz, Executive VP, mdi Consultants, Inc. has been invited to join the Editorial Advisory Board of MDT (Medical Device Technology)
    Click here for details

    

INQUIRIES

To Inquire about our services, use the link below:
 Inquiry Form

to sign up for our Newsletter, Use the link below:

The mdi Consultants e-mail list sign-up form



CONTACT

Contact mdiConsulatnts, Inc.


mdiConsultants, Inc.
55 Northern Blvd
Great Neck, NY 11021


General Information: 1-516-482-9001
FAX:  1-516-482-0186
Click here to
contact us



FDA Recalls for t

FDA Recalls

January 1, 2008 -  June 30, 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