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FDA Recalls

January 1, 2006 - June 30, 2006

• Recalls as of June 28, 2006
• Recalls as of June 21, 2006
• Recalls as of June 14, 2006
• Recalls as of June 7, 2006
• Recalls as of May 31, 2006
• Recalls as of May 24, 2006
• Recalls as of May 17, 2006
• Recalls as of May 10, 2006
• Recalls as of May 3, 2006
• Recalls as of April 26, 2006
• Recalls as of April 19, 2006
• Recalls as of April 12, 2006
• Recalls as of April 5, 2006
• Recalls as of March 29, 2006
• Recalls as of March 22, 2006
• Recalls as of March 15, 2006
• Recalls as of March 8, 2006
• Recalls as of March 1, 2006
• Recalls as of February 22, 2006
• Recalls as of February 15, 2006
• Recalls as of February 8, 2006
• Recalls as of February 1, 2006
• Recalls as of January 25, 2006
• Recalls as of January 18, 2006
• Recalls as of January 11, 2006
• Recalls as of January 4, 2006

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 28, 2006:

CLASS I

MANUFACTURER: MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL, by press release and letters on June 15, 2006. Firm initiated recall is ongoing.
PRODUCT: Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Model AED20, part 972200, catalog # 972211, 972212, 972213, 972214, 972215 and 972216; Recall # Z-1106-06
REASON: The Welch Allyn AED 20 Defibrillators may display a “Defib Comm” error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

CLASS II

MANUFACTURER: Alcon Laboratories, Inc., Orlando, FL, by letter dated August 1, 2005. Firm initiated recall is ongoing.
PRODUCT: LADARVision Excimer Laser System, Recall # Z-1147-06
REASON: A software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on Custom Cornea procedures, possibly adversely affecting clinical outcomes.

MANUFACTURER: Recalling Firm: United States Surgical, North Haven, CT, by letter dated May 22, 2006. Manufacturer: B. Braun Medical, Inc., Allentown, PA, firm initiated recall is ongoing.
PRODUCT: a) Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021 Recall # Z-1148-06
b) Auto Suture ChemoSite Low Profile Venous Access System with 9FR Introducer Kit with Silicone Catheter Catalog Number: 120025. Recall # Z-1149-06
c) Auto Suture ChemoSite Catheter 9FR Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120039. Recall # Z-1150-06
d) Auto Suture ChemoSite Implantable Venous Kit Access System with 9FR Introducer Kit Catalog Number: 120045. Recall # Z-1151-06
e) Auto Suture ChemoSite Catheter Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120049. Recall # Z-1152-06
f) Auto Suture ChemoSite Implantable Venous Access System with 9FR Introducer Kit with Silicone Catheter Catalog Number: 120066. Recall # Z-1153-06
REASON: The 9F device may contain a 10 F sheath instead of the 9F.

MANUFACTURER: Recalling Firm: Abbott Spine, Austin, TX, by telephone on May 15, 2006 Manufacturer: Sterimed, Inc., Cartersville, GA, firm initiated recall is ongoing.
PRODUCT: Stericover/ Sterile Disposable Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96'', Recall # Z-1154-06
REASON: Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.

MANUFACTURER: Stryker Medical Div. of Stryker Corporation, Portage, MI, by telephone on May 15, 2006. Firm initiated recall is ongoing.
PRODUCT: Stryker Trio Mobile Surgery Platform; Model 1033, Recall # Z-1155-06
REASON: An incorrect pin may have been used during assembly and therefore the device may give way during use.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 21, 2006:

CLASS II

MANUFACTURER: Fanlight Corporation Inc., City of Industry, CA, by letters on March 24, 2006. Firm initiated recall is ongoing.
PRODUCT: a) PlusRite Power Strike Metal Halide Lamps, Recall # Z-0450-06;
b) PlusRite Low Watt Metal Halide Lamps, Recall # Z-0451-06;
c) PlusRite Universal Metal Halide Lamps, Recall # Z-0452-06;
d) PlusRite Protected Metal Halide Lamps, Recall # Z-0453-06;
e) PlusRite Mercury Vapor Lamps, Recall # Z-0454-06
REASON: The non-self-extinguishing mercury vapor and metal halide lamps failed to comply with the performance requirements of 21 CFR 1040.30 and the certification and identification requirements of 21 CFR 1010.2 and 1010.3.

MANUFACTURER: Edwards Lifesciences Research Medical, Inc., Midvale, UT, by letter and visit beginning April 18, 2006. Firm initiated recall is ongoing.
PRODUCT: a) Aortic Perfusion Cannula with plastic tip, 22 Fr. X 28 cm Edwards
Lifesciences, REF: A3221190A, Recall # Z-1089-06;
b) Duraflow Treated Aortic Perfusion Cannula with plastic tip,
22 Fr. X 28 cm Edwards Lifesciences, REF: DARH221190TA,
Recall # Z-1090-06;
c) Aortic Perfusion Cannula with plastic tip, 22 Fr. X 28 cm Edwards
Lifesciences, REF: ARH221190TA, Recall # Z-1091-06;
d) Duraflow Treated Aortic Perfusion Cannula with plastic tip,
22 Fr. X 28 cm Edwards Lifesciences, REF: DARH221190A,
Recall # Z-1092-06;
e) Aortic Perfusion Cannula with plastic tip, 22 Fr. X 23 cm Edwards
Lifesciences, REF: AH221190A, Recall # Z-1093-06;
f) Aortic Perfusion Cannula with metal tip, 22 Fr. X 23 cm Edwards
Lifesciences, REF: MT022A, Recall # Z-1094-06;
g) Aortic Perfusion Cannula with metal tip, 22 Fr. X 23 cm Edwards
Lifesciences, REF: MT022TA, Recall # Z-1095-06
REASON: Due to potential embrittlement of the plastic tip which may crack or separate during use.

MANUFACTURER: Recalling Firm: Teleflex Corporation, Limmerick, PA, by letters dated April 18, 2006. Manufacturer: Teleflex Medical, Research Triangle Park, NC. Firm initiated recall is ongoing.
PRODUCT: a) Weck Hem-o-lok ML Polymer Ligating Clips; Rx, sterile, medium
large size, non-absorbable polymer ligation clips; 6 clips per cartridge,
14 cartridges per sales unit, 12 sales units per case, catalog number
544230, Recall # Z-1096-06;
b) Weck Hem-o-lok L Polymer Ligating Clips; Rx, sterile, large size,
non-absorbable polymer ligation clips; 6 clips per cartridge,
14 cartridges per sales unit, 12 sales units per case, catalog number
544240, Recall # Z-1097-06;
c) Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, extra large
size, non-absorbable polymer ligation clips; 6 clips per cartridge,
14 cartridges per sales unit, 12 sales units per case, catalog number
544250, Recall # Z-1098-06;
d) Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer
Ligating Clips; Rx, sterile, single use, disposable clip applier with
medium size, non-absorbable polymer ligation clips; 15 clips per applier,
3 appliers per sales unit, 6 units per case, catalog number 543965,
Recall # Z-1099-06
REASON: The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.

MANUFACTURER: Applied Biotech, Inc., San Diego, CA, by letter on May 8, 2006. Firm initiated recall is ongoing.
PRODUCT: Signify hCG Serum Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI, Recall # Z-1100-06
REASON: Certain kits from the product lot may contain test devices which contain incorrect reaction strips. Use of such devices may produce false negative results with patient samples at and above the limit of detection of the product.

MANUFACTURER: Recalling Firm: Ethicon, Inc., Somerville, NJ, by letters on April 27, 2006. Manufacturer: Accellent, Inc., Laconia, NH. Firm initiated recall is ongoing.
PRODUCT: Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDNN242, EDNN243, and EDNN244, Recall # Z-1101-06
REASON: During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.

MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove, MN, by letter, dated May 22, 2006. Manufacturer: Avenida Norske Edificio G1 Local B, Tijuana, Mexico. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific Wiseguide Guide Catheter 7F, .076', Femoral Approach. Catalog number: 19500-448, Catalog number: 19500-498, Catalog number: 19500-08, Catalog number: 19500-09, Catalog number: 19500-132, Catalog number: 19500-27, Recall # Z-1102-06
REASON: Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery.

MANUFACTURER: Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by letter dated January 27, 2006. Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT: Hitachi Altaire Magnetic Resonance Imaging System, Recall # Z-1103-06
REASON: Circuit Failure -- There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the systems main breaker when 2 of the 3 power phases are lost.

MANUFACTURER: Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by service technicians beginning on April 28, 2006. Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT: Altaire Nuclear Magnetic Resonance Imaging Device Systems, Recall # Z-1104-06
REASON: Software anomaly -- A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis.

MANUFACTURER: Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visits beginning on March 17, 2006. Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT: MRP-7000, AIRIS Magnetic Resonance Imaging Systems, Recall # Z-1105-06
REASON: Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error could result in a possible patient mis-diagnosis.

MANUFACTURER: Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visits beginning on April 25, 2006. Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT: Hitachi AIRIS II MRI Nuclear Magnetic Resonance Imaging System, Recall # Z-1115-06
REASON: Improper Assembly-The AIRIS/AIRIS II MRI system has the potential for the input wiring of a power transformer to overheat due to damaged wiring or possible loose connections.

MANUFACTURER: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter on April 14, 2006. Firm initiated recall is complete.
PRODUCT: 8mm SATELLITE™ Sphere CoCr contained in a SATELLITE™ Spinal System (internal fixation device-vertebral stabilization/fusion), Recall # Z-1088-06
REASON: Device marketed without 510 (k) or PMA clearance.

CLASS III

MANUFACTURER: Ev3, Inc, Plymouth, MN, by letter dated February 13, 2006. Firm initiated recall is ongoing.
PRODUCT: a) X-Sizer Thrombectomy Catheter System (ev3) Model number
XD-CS1150-45 (for US distribution). Model number XR-CS1150-45
(for foreign distribution). 1.5mm. Sterilization with Ethylene Oxide Gas.
Recall # Z-1107-06;
b) X-Sizer Thrombectomy Catheter System (ev3) Model number
XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm. Sterilization with Ethylene Oxide Gas, Recall # Z-1108-06
REASON: Loss of Operating Vacuum during use. It has been determined that a small percentage of X-Sizer Thrombectomy Catheter Systems from specific lots may lose operating vacuum prematurely due to a system leak within the Control Module. This failure can lead to the inability to complete the procedure of thrombus removal and the necessity to remove the device prior to achieving a satisfactory result.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 14, 2006:

CLASS II

MANUFACTURER: General Electric Med Systems, LLC, Waukesha, WI, by letter dated November 10, 2005. Firm initiated recall is ongoing.
PRODUCT: Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. Recall # Z-0588-06
REASON: The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.

MANUFACTURER: Exactech, Inc., Gainesville, FL, by letter on December 19, 2005. Firm initiated recall is ongoing.
PRODUCT: Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY*** ***.'' Catalogue number 200-04-45, Recall # Z-0927-06
REASON: An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place.

MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone beginning February 22, 2006. Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
PRODUCT: Gliding Nail Radiolucent Guide instrument set, Model Number: GNRADIOLUCENTGUIDE, instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125° 1130023-A: GN Targeting Guide Carbon 135° 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve Recall # Z-0928-06
REASON: PLUS USA has been informed by PLUS AG that the accuracy of the instrument set may be affected in some cases. It is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments.

MANUFACTURER: Datascope Corp, Mahwah, NJ, by letter on March 17, 2006. Firm initiated recall is ongoing.
PRODUCT: Anestar and Anestar Plus Anesthesia System. Recall # Z-0929-06
REASON: The Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pressure Limit (APL) valve.

MANUFACTURER: Medtronic, Inc., Danvers, MA, by letter on April 5, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) CATHETER LA5IMAA 5F 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model #: LA5IMAA, Recall # Z-0930-06;
b) CATH.GUIDE 5F JL 4.0 110CM CATHETER LA5JL40A LA 5F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model # LA5JL40A, Recall # Z-0931-06;
c) CATH.GUIDE 5F JR 4.0 110CM CATHETER LA5JR40A LA 5F 110CM JR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model #LA5JR40A, Recall # Z-0932-06;
d) CATH GUIDE 5F SR3.0 LAUNCHER CATHETER LA5SR30 LA 5F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model#LA5SR30, Recall # Z-0933-06;
e) CATH GUIDE 5F SR3.5 LAUNCHER CATHETER LA5SR35 LA 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA5SR35, Recall # Z-0934-06;
f) CATH GUIDE 5F SR4.0 LAUNCHER CATHETER LA5SR40 LA 5F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA5SR40, Recall # Z-0935-06;
g) CATH.GUIDE 5F SR 5.0 110CM CATHETER LA5SR50A LA 5F 110CM SR5 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA5SR50A, Recall # Z-0936-06;
h) CATH. GUIDE 6F 3DRC LAUNCHER CATHETER LA63DRC LA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number:LA63DRC, Recall # Z-0937-06;
i) CATH. GUIDE 6F AL 1.0 110CM LA CATHETER LA6AL10A LA 6F 110CM AL10 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6AL10A, Recall # Z-0939-06;
j) CATH. GUIDE 6F AL 2.0 110CM LA CATHETER LA6AL20A LA 6F 110CM AL20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6AL20A, Recall # Z-0940-06;
k) CATH GUIDE 6F LAUNCHER AL 3.0 CATHETER LA6AL30A LA 6F 110CM AL30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6AL30A, Recall # Z-0941-06;
l) CATH. GUIDE 6F EBU3.5 110CM LA CATHETER LA6EBU35A LA 6F 110CM EB35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6EBU35A, Recall # Z-0942-06;
m) CATH. GUIDE 6F EBU4.0 110CM LA CATHETER LA6EBU40A LA 6F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6EBU40A, Recall # Z-0943-06;
n) CATH GUIDE 6F LAUNCHER EBU 4.5 CATHETER LA6EBU45A LA 6F 110CM EB45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6EBU45A, Recall # Z-0944-06;
o) CATHETER LA6HSIA 6F 110CM HSI Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number : LA6HSIA, Recall # Z-0945-06;
p) CATH. GUIDE 6F JL3.5 110CM LAU CATHETER LA6JL35A LA 6F 110CM JL35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL35A, Recall # Z-0946-06;
q) CATH. GUIDE 6F JL4.0 5 PACK LA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL405, Recall # Z-0947-06;
r) CATH. GUIDE 6F JL4.0 110CM LAU CATHETER LA6JL40A LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL40A, Recall # Z-0948-06;
s) CATH.GUIDE 6F JL 4.0 SH 110CM CATHETER LA6JL40SHA LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL40SHA, Recall # Z-0949-06;
t) CATHETER LA6JL45A 6F 110CM JL4 CATHETER LA6JL45A 6F 110CM JL45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL45A, Recall # Z-0950-06;
u) CATH. GUIDE 6F JL5.0 110CM LAU CATHETER LA6JL50A LA 6F 110CM JL50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL50A, Recall # Z-0951-06;
v) CATH. GUIDE 6F JR4.0 110CM LAU CATHETER LA6JR40A LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR40A, Recall # Z-0952-06;
w) CATH.GUIDE 6F JR 4.0 SH 110CM CATHETER LA6JR40SHA LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR40SHA, Recall # Z-0953-06;
x) CATH. GUIDE 6F JR5.0 110CM LAU CATHETER LA6JR50A LA 6F 110CM JR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR50A, Recall # Z-0954-06;
y) CATHETER LA6MB1A LA 6F 110CM M Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6MB1A, Recall # Z-0955-06;
z) CATH. GUIDE 6F SR3.0 LAUNCHER CATHETER LA6SR30 LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR30, Recall # Z-0956-06;
aa) CATH. GUIDE 6F SR3.0 W/SH LAUN CATHETER LA6SR30SH LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR30SH, Recall # Z-0957-06;
bb) CATH. GUIDE 6F SR3.5 LAUNCHER CATHETER LA6SR35 LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR35, Recall # Z-0958-06;
cc) CATH. GUIDE 6F SR3.5 W/SH LAUN CATHETER LA6SR35SH LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR35SH, Recall # Z-0959-06;
dd) CATH. GUIDE 6F SR4.0 LAUNCHER CATHETER LA6SR40 LA 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR40,
Recall # Z-0960-06;
ee) CATHETER LA6SR40A 6F 110CM SR4 CATHETER LA6SR40A 6F 110CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code:
LA6SR40A, Recall # Z-0961-06:
ff) CATH. GUIDE 6F SR4.0 W/SH LAUN CATHETER LA6SR40SH LA 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR40SH, Recall # Z-0962-06;
gg) CATH. GUIDE 6F SR4.5 LAUNCHER CATHETER LA6SR45 LA 6F 100CM SR45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR45, Recall # Z-0963-06;
hh) CATH. GUIDE 6F SR4.5 W/SH LAUN CATHETER LA6SR45SH LA 6F 100CM SR45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR45SH, Recall # Z-0964-06;
ii) CATH. GUIDE 6F SR5.0 LAUNCHER CATHETER LA6SR50 LA 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR50, Recall # Z-0965-06;
jj) CATH. GUIDE 6F SR5.0 W/SH LAUN CATHETER LA6SR50SH LA 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR50SH, Recall # Z-0966-06;
kk) CATH. GUIDE 6F SR6.0 LAUNCHER CATHETER LA6SR60 LA 6F 100CM SR60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR60, Recall # Z-0967-06;
ll) CATH. GUIDE 6F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR60SH, Recall # Z-0968-06;
mm) CATH. GUIDE 7F 3DRCC LAUNCHER CATHETER LA73DRC LA 7F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA73DRC, Recall # Z-0969-06;
nn) CATHETER LA7IMAA LA 7F 110CM I CATHETER LA7IMAA LA 7F 110CM IMA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7IMAA, Recall # Z-0970-06;
oo) CATHETER LA7MB1A LA 7F 110CM M CATHETER LA7MB1A LA 7F 110CM MB Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7MB1A, Recall # Z-0971-06;
pp) CATH. GUIDE 7F SR3.0 LAUNCHER CATHETER LA7SR30 LA 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR30, Recall # Z-0972-06;
qq) CATH. GUIDE 7F SR3.0 W/SH LAUN CATHETER LA7SR30SH LA 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA7SR30SH, Recall # Z-0973-06;
rr) CATH. GUIDE 7F SR3.5 LAUNCHER CATHETER LA7SR35 LA 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA7SR35 LA7SR35, Recall # Z-0974-06;
ss) CATH. GUIDE 7F SR3.5 W/SH LAUN CATHETER LA7SR35SH LA 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR35SH, Recall # Z-0975-06;
tt) CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR40, Recall # Z-0976-06;
uu) CATH. GUIDE 7F SR4.0 W/SH LAUN CATHETER LA7SR40SH LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR40SH, Recall # Z-0977-06;
vv) CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA7SR40, Recall # Z-0978-06;
ww) CATH. GUIDE 7F SR4.0 W/SH LAUN CATHETER LA7SR40SH LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR40SH, Recall # Z-0979-06;
xx) CATH. GUIDE 7F SR5.0 LAUNCHER CATHETER LA7SR50 LA 7F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR50, Recall # Z-0980-06;
yy) CATH. GUIDE 8F 3DRC LAUNCHER CATHETER LA83DRC LA 8F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA83DRC, Recall # Z-0981-06;
zz) CATH. GUIDE 8F 3DRC W/SH LAUNC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA83DRCSH, Recall # Z-0982-06;
aaa) CATH.GUIDE 8F EBU 4.0 110CM CATHETER LA8EBU40SHA LA 8F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8EBU40SHA, Recall # Z-0983-06;
bbb) CATH.GUIDE 8F EBU 4.5 SH 110CM CATHETER LA8EBU45SHA LA 8F 110CM EB45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA8EBU45SHA,Recall # Z-0984-06;
ccc) CATH.GUIDE 8F EBU 5.0 SH 110CM CATHETER LA8EBU50SHA LA 8F 110CM EB50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8EBU50SHA, Recall # Z-0985-06;
ddd) CATH. GUIDE 8F SR3.0 LAUNCHER Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR30, Recall # Z-0986-06;
eee) CATH. GUIDE 8F SR3.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR30SH, Recall # Z-0987-06;
fff CATH. GUIDE 8F SR3.5 LAUNCHER CATHETER LA8SR35 LA 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR35, Recall # Z-0988-06;
ggg) CATH. GUIDE 8F SR3.5 W/SH LAUN CATHETER LA8SR35SH LA 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR35SH, Recall # Z-0989-06;
hhh) CATH. GUIDE 8F SR4.0 LAUNCHER CATHETER LA8SR40 LA 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR40, Recall # Z-0990-06;
iii) CATH. GUIDE 8F SR4.0 W/SH LAUN CATHETER LA8SR40SH LA 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR40SH, Recall # Z-0991-06;
jjj) CATH. GUIDE 8F SR5.0 LAUNCHER Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR50, Recall # Z-0992-06;
kkk) CATH. GUIDE 8F SR5.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR50SH, Recall # Z-0993-06;
lll) CATH. GUIDE 8F SR6.0 LAUNCHER Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA8SR60, Recall # Z-0994-06;
mmm) CATH. GUIDE 8F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA8SR60SH, Recall # Z-0995-06;
nnn) CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SA63DRC, Recall # Z-0996-06;
ooo) CATHETER SA63DRCSH Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SA63DRCSH, Recall # Z-0997-06;
ppp) CATHETER SA6SR35 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SA6SR35, Recall # Z-0998-06;
qqq) CATHETER SA6SR40 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SA6SR40, Recall # Z-0999-06;
rrr) CATHETER SA6SR50 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SA6SR50, Recall # Z-1000-06;
sss) CATHETER SB63DRC SB 6F 100CM 3 CATHETER SB63DRC SB 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB63DRC, Recall # Z-1001-06;
ttt) CATHETER SB63DRCSH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB63DRCSH, Recall # Z-1002-06;
uuu) CATHETER SB6SR30 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB6SR30, Recall # Z-1003-06;
vvv) CATHETER SB6SR35 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB6SR35, Recall # Z-1004-06;
www) CATHETER SB6SR35SH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB6SR35SH, Recall # Z-1005-06;
xxx) CATHETER SB6SR40 SB 6F 100CM S CATHETER SB6SR40 SB 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB6SR40, Recall # Z-1006-06;
yyy) CATHETER SB6SR40SH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB6SR40SH, Recall # Z-1007-06;
zzz) CATHETER SB6SR50 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB6SR50, Recall # Z-1008-06;
aaaa) CATHETER SB73DRCSH SB 7F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB73DRCSH, Recall # Z-1009-06;
bbbb) CATHETER Z26AL10A Z2 6F 110CM AL10 Z26 AL10 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AL10A, Recall # Z-1010-06;
cccc) 6F Z2 AL 2.0 110CM CATHETER Z26AL20A Z2 6F 110CM AL20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AL20A, Recall # Z-1011-06;
dddd) 6F Z2 AL 3.0 110CM CATHETER Z26AL30A Z2 6F 110CM AL30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AL30A, Recall # Z-1012-06;

eeee) 6F Z2 AR 2.0 110CM CATHETER Z26AR20A Z2 6F 110CM AR20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AR20A, Recall # Z-1013-06;
ffff) CATHETER Z26EBU35A Z2 6F 110CM EB35 Z26 EBU35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26EBU35A, Recall # Z-1014-06;
gggg) CATHETER Z26EBU40A Z2 6F 110CM CATHETER Z26EBU40A Z2 6F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26EBU40A, Recall # Z-1015-06;
hhhh) 6F Z2 FL 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product code: Z26FL40A, Recall # Z-1016-06;
iiii) 6F Z2 JL 4.0 110CM CATHETER Z26JL40A Z2 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26JL40A, Recall # Z-1017-06;
jjjj) 6F Z2 JR 4.0 110CM CATHETER Z26JR40A Z2 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26JR40A, Recall # Z-1018-06;
kkkk) CATH, GUIDE 6F JR4.0 SH 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26JR40SHA, Recall # Z-1019-06;
llll) CATH GUIDE 6F MB2 110CM Z2 CATHETER Z26MB2A Z2 6F 110CM MB2 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26MB2A, Recall # Z-1020-06;
mmmm) 6F Z2 MP1 110CM CATHETER Z26MP1A Z2 6F 110CM MP1 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26MP1A, Recall # Z-1021-06;
nnnn) 6F Z2 GUIDING CATHETER SR3.0 CATHETER Z26SR30 Z2 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR30, Recall # Z-1022-06;
oooo) 6F Z2 GUIDING CATH SR3.0 SH CATHETER Z26SR30SH Z2 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR30SH, Recall # Z-1023-06;
pppp) 6F Z2 GUIDING CATHETER SR3.5 CATHETER Z26SR35 Z2 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR35, Recall # Z-1024-06;
qqqq) 6F Z2 GUIDING CATH SR3.5 SH CATHETER Z26SR35SH Z2 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR35SH, Recall # Z-1025-06;
rrrr) 6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR40, Recall # Z-1026-06;
ssss) 6F Z2 GUIDING CATH SR4.0 SH CATHETER Z26SR40SH Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26SR40SH, Recall # Z-1027-06;
tttt) 6F Z2 GUIDING CATHETER SR5.0 CATHETER Z26SR50 Z2 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26SR50, Recall # Z-1028-06;
uuuu) 6F Z2 GUIDING CATH SR5.0 SH CATHETER Z26SR50SH Z2 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26SR50SH, Recall # Z-1029-06;
vvvv) 7F Z2 FR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27FR40A, Recall # Z-1030-06;
wwww) 7F Z2 JL 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27JL40A, Recall # Z-1031-06;
xxxx) 7F ZUMA 2 JR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27JR40A, Recall # Z-1032-06;
yyyy) 7F Z2 MB2 110CM CATHETER Z27MB2A Z2 7F 110CM MB2 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code:Z27MB2A, Recall # Z-1033-06;
zzzz) 7F Z2 MP1 110CM CATHETER Z27MP1A Z2 7F 110CM MP1 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27MP1A, Recall # Z-1034-06;
aaaaa) 7F ZUMA 2 SR3.0 100CM CATHETER Z27SR30 Z2 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR30, Recall # Z-1035-06;
bbbbb) 7F ZUMA 2 SR3.5 100CM CATHETER Z27SR35 Z2 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR35, Recall # Z-1036-06;
ccccc) 7F ZUMA 2 SR3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR35SH, Recall # Z-1037-06;
ddddd) 7F ZUMA 2 SR4.0 100CM CATHETER Z27SR40 Z2 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27SR40, Recall # Z-1038-06;
eeeee) 7F ZUMA 2 SR4.0 SH 100CM CATHETER Z27SR40SH Z2 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27SR40SH, Recall # Z-1039-06;
fffff) 7F ZUMA 2 SR5.0 100CM CATHETER Z27SR50 Z2 7F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR50, Recall # Z-1040-06;
ggggg) CATH. GUIDE 8F AR1.0 W/SH 110C Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28AR10SHA, Recall # Z-1041-06;
hhhhh) CATH. GUIDE 8F EBU3.5 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28EBU35SHA, Recall # Z-1042-06;
iiiii) CATH. GUIDE 8F EBU4.0 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product code: Z28EBU40SHA, Recall # Z-1043-06;
jjjjj) CATH. GUIDE 8F EBU5.0 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28EBU50SHA, Recall # Z-1044-06;
kkkkk) CATH. GUIDE 8F FR4.0 W/SH 110C Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28FR40SHA, Recall # Z-1045-06;
lllll) CATH. GUIDE 8F MB1 W/SH 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28MB1SHA, Recall # Z-1046-06;
mmmmm) 8F ZUMA 2 SR 3.0 100CM CATHETER Z28SR30 Z2 8F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR30, Recall # Z-1047-06;
nnnnn) 8F ZUMA 2 SR 3.5 100CM CATHETER Z28SR35 Z2 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35, Recall # Z-1048-06;
ooooo) 8F ZUMA 2 SR 3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35SH, Recall # Z-1049-06;
ppppp) 8F ZUMA 2 SR 4.0 100CM CATHETER Z28SR40 Z2 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40, Recall # Z-1050-06;
qqqqq) 8F ZUMA 2 SR 4.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40SH, Recall # Z-1051-06;
rrrrr) 8F ZUMA 2 SR 5.0 100CM CATHETER Z28SR50 Z2 8F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50, Recall # Z-1052-06;
sssss) 8F ZUMA 2 SR 5.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50SH, Recall # Z-1053-06;
ttttt) 5F ZUMA SR3.0 CATHETER ZM5SR30 Z2 5F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR30, Recall # Z-1054-06;
uuuuu) ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR35, Recall # Z-1055-06;
vvvvv) 5F ZUMA SR4.0 CATHETER ZM5SR40 Z2 5F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR40, Recall # Z-1056-06;
wwwww) 5F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR50, Recall # Z-1057-06;
xxxxx) 6F ZUMA AL1.0 W/110CM LENGTH CATHETER ZM6AL10A ZM 6F 110CM AL1.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6AL10A, Recall # Z-1058-06;
yyyyy) 6F ZUMA AL1.0 W/110CM LENGTH CATHETER ZM6AL10A ZM 6F 110CM AL1.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6AL10A, Recall # Z-1059-06;
zzzzz) 6F ZUMA AR2.0 CATHETER ZM6AR20A ZM 6F 110CM AR2.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6AR20A, Recall # Z-1060-06;
aaaaaa) 6F ZUMA DC3.5 W/110CM LENGTH GUID CATH 6F ZUMA DC 3.5 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Codes: ZM6DC35A , ZM6DC35A00, Recall # Z-1061-06;
bbbbbb) 6F ZUMA DC4.0 W/110CM LENGTH GUID CATH 6F ZUMA DC 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Codes: ZM6DC40A ,ZM6DC40A00, Recall # Z-1062-06;
cccccc) 6F ZUMA EBU3.5 W/110CM LENGTH CATHETER ZM6EBU35A ZM 6F 110CM EB35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6EBU35A, Recall # Z-1063-06;
dddddd) 6F ZUMA EBU4.0 W/110CM LENGTH GUID CATH 6F ZUMA EBU4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6EBU40A, ZM6EBU40A00, Recall # Z-1064-06;
eeeeee) ZM6JL40A 6F ZUMA JL40 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JL40A, Recall # Z-1065-06;
ffffff) 6F ZUMA JL40 110CM CATHETER ZM6JL40A ZM 6F 110CM JL4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JL40A, Recall # Z-1066-06;
gggggg) CATH, GUIDE 6F JL6.0 110CM ZUM CATHETER ZM6JL60A ZM 6F 110CM JL60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JL60A, Recall # Z-1067-06;
hhhhhh) ZM6JR40A 6F ZUMA JR4.0 110CM CATHETER ZM6JR40A ZM 6F 110CM JR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JR40A, Recall # Z-1068-06;
iiiiii) 6F ZUMA JR5.0 110CM CATHETER ZM61JR50A ZM 6F 110CM JR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JR50A, Recall # Z-1069-06;
jjjjjj) 6F ZUMA MAC 3.5 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6MAC35A, Recall # Z-1070-06;
kkkkkk) 6F ZUMA MAC 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6MAC40A, Recall # Z-1071-06;
llllll) 6F ZUMA SL5.0 CATHETER ZM6SL50 ZM 6F 100CM SL5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SL50, Recall # Z-1072-06;
mmmmmm) 6F ZUMA SR3.0 CATHETER ZM6SR30 ZM 6F 100CM SR3.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR30, Recall # Z-1073-06;
nnnnnn) 6F ZUMA SR3.5 CATHETER ZM6SR35 ZM 6F 100CM SR3.5 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR35, Recall # Z-1074-06;
oooooo) 6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR40, Recall # Z-1075-06;
pppppp) 6F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR50, Recall # Z-1076-06
REASON: Potential for non-sterility due to loss of package integrity.

MANUFACTURE: Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on February 21, 2006. Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT: Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT), Recall # Z-1078-06
REASON: The device has a software anomaly which affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them.

MANUFACTURER: Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on February 21, 2006. Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT: Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT). Recall # Z-1079-06
REASON: The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized.

MANUFACTURER: Guidant Endovascular Solutions, Inc., Temecula, CA, by letter dated April 3, 2006. Firm initiated recall is ongoing.
PRODUCT
a) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part F#1010563, Recall # Z-1080-06;
b) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010564, Recall # Z-1081-06;
c) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010565, Recall # Z-1082-06;
d) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566, Recall # Z-1083-06;
e) ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)- Base Part #FG1010567, Recall # Z-1084-06;
f) ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010568, Recall # Z-1085-06
REASON: Design: increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action.

MANUFACTURER: St. Jude Medical / Daig Division, Minnetonka, MN, by letter dated April 13, 2006. Firm initiated recall is ongoing
PRODUCT: St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308, Agilis Steerable Catheter Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. EXPANDED RECALL The Reorder number affected by the recall expansion is 408304. Recall # Z-1086-06
REASON: St Jude Medical has determined that a limited number of Agilis Steerable Introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. The risks that exist are related to the loss of hemostasis through the Agilis introducer and/or the possibility of air or foreign body being introduced.

 MANUFACTURER: Ethicon, Inc., Somerville, NJ, by letter on May 4, 2006. Firm initiated recall is ongoing.
PRODUCT: Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide. Recall # Z-1087-06
REASON: Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures

CLASS III

MANUFACTURER: Ev3, Inc., Plymouth, MA, by letter on December 29, 2005. Firm initiated recall is complete.
PRODUCT: Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Minnesota, 55442-2920 USA. For one time use only. Sterilization with Ethylene Oxide gas. Do not resterilize.------The Amplatz Goose Neck Microsnare Kit contains one Amplatz Goose Neck Microsnare, one Microcatheter, one Microsnare Introducer and one torque device. Recall # Z-0894-06
REASON: ev3 has determined that one test unit from each of two lots did not meet minimum tensile strength requirements and therefore the entire lots are being recalled

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 7, 2006:

CLASS II

MANUFACTURER: Rita Medical Systems, Inc., One Horizon Way, Manchester, GA., by telephone on May 2, 2006 and by letter and email on May 3, 2006. Firm initiated recall is ongoing.
PRODUCT: a) Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. *
StarBurst™ Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R *
Catalog # 700-102846-RITA® *, Recall # Z-0887-06;
b) XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. *
StarBurst™ Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm
Diameter * 12cm Length * Sterile/R * RITA® * , Recall # Z-0888-06
REASON: Misbranding: Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.

MANUFACTURER: Ethicon, Inc., Somerville, NJ, by letter on March 28, 2006. Firm initiated recall is ongoing.
PRODUCT: Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The suture is coated with a copolymer composed of 90% caprolactone and 10% glycolide, Recall # Z-0907-06
REASON: The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations.

MANUFACTURER: Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visits beginning on February 21, 2006. Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT: Magnetic Resonance Imaging Device, Recall # Z-0910-06
REASON: The device has a software anomaly which causes the operating system to lock up and data to become corrupted during service procedures.

MANUFACTURER: Ev3, Inc., Plymouth, MN, by visits on April 12, 2006. Firm initiated recall is ongoing.
PRODUCT: ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon. Model number BXB35-05-17-120 and Model number BXB35-06-17-120, Recall # Z-0912-06
REASON: A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.

MANUFACTURER: Recalling Firm: Bard Peripheral Vascular, Inc., Tempe, AZ, by letters on May 1, 2006. Manufacturer: Bard Reynosa S.A. De C.V., Reynosa, Mexico. Firm initiated recall is ongoing.
PRODUCT: Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listing Number E148687. The Bard TruGuide Coaxial Biopsy Needle is a three-part device consisting of an outer cannula with an attached female luer lock hub, and inner stylet with an attached male luer lock hub, and a flexible slip rink depth stop, Recall # Z-0913-06
REASON; Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected.

MANUFACTURER: EP Medsystems, West Berlin, NJ, by letter on April 4, 2006. Firm initiated recall is ongoing.
PRODUCT: EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings using built-in protocols, and includes an emergency stimulation function, Recall # Z-0914-06
REASON: Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation unit-2)-Presence of a DC offset voltage on an output channel-3)-Inability to synchronize with a non-EP MedSystems recording system.

MANUFACTURER: Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter on April 24, 2006. Manufacturer: Ethicon Endo-Surgery, Inc., S.A. de C.V. Planta II, Ciudad Juarez, Mexico. Firm initiated recall is ongoing.
PRODUCT: a) Endopath Probe Plus II, Hook Electrode, 5 mm Shaft, 34 cm length,
hollow tip electrdode, Product Code EPS01, Recall # Z-0915-06;
b) Endopath Probe Plus II, Foot-Controlled PistolGrip Handle, Product Code EPH01,
Recall # Z-0916-06;
c) Endopath Probe Plus II, Hand-Controlled PistolGrip Handle, Product Code EPH02,
Recall # Z-0917-06;
d) Endopath Probe Plus II, Hand Controlled PencilGrip Handle, Product Code EPH04,
Recall # Z-0918-06;
e) Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip
electrode, Product Code EPS02, Recall # Z-0919-06;
f) Endopath Probe Plus II, Right Ange Electrode, 5 mm shaft, 34 cm length, hollow tip
electrode, Product Code EPS03, Recall # Z-0920-06;
g) Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 34 cm length, hollow
tip electrode, Code EPS04, Recall # Z-0921-06;
h) Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 29cm length, hollow tip
electrode, Code EPS06, Recall # Z-0922-06;
i) Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 29cm length,
hollow tip electrode, Code EPS08, Recall # Z-0923-06;
j) Endopath Probe Plus II, Needle Electrode, 5mm shaft, 29cm length, hollow tip
electrode, Code EPS09, Recall # Z-0924-06;
k) Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm
length, Code EPS11, Recall # Z-0925-06;
l) Endopath Probe Plus II, Flexible Fiber Canula, 5mm shaft, 29cm length, Code EPS13,
Recall # Z-0926-06
REASON: There is a possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.

MANUFACTURER: Catheter Research, Inc., Indianapolis, IN, by letter dated April 24, 2006. Firm initiated recall is ongoing.
PRODUCT: Zinnanti Injector -- 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin’s test. REF TMI1153, Recall # Z-1077-06

REASON: The uterine stop component was not included with the device.

CLASS III

MANUFACTURER: Recalling Firm: Medtronic Neurological, Minneapolis, MN, by letter on March 2006. Manufacturer: Medtronic Puerto Rico Operations Co, MedRel, Juncos, PR. Firm initiated recall is ongoing.
PRODUCT: Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Kinetra neurostimulator is a component of the Activa System. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The dual program Model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case, Recall # Z-0861-06
REASON: A specific subset of model 7428 Kinetra implantable neurostimulators may fail due to lifted wirebonds between the hybrid circuit and battery. This failure mechanism may present clinically as loss of functionality and a return of the patient's underlying medical conditions.

MANUFACTURER: Recalling Firm: Medtronic Inc., Cardiac Rhythm Management, Minneapolis, MN, by telephone and/ or letter in February 2006. Manufacturer: Medtronic Paceart, Arden Hills, MN. Firm initiated recall is ongoing.
PRODUCT: Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken directly from the patient or programmer. The system can measure, store, and display any of the 12 standard leads. Reports and charts are available by means of a laser printer. The system also includes a database that collects and stores patient data. Optional software allows the device to function as an unattended transtelephonic receiving station, Recall # Z- 0911-06
REASON: The Paceart System could inappropriately insert data from a patient’s Medtronic CareLink transmission into another patient’s Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 31, 2006:

CLASS II

MANUFACTURER: Recalling Firm: Kinetic Concepts, Inc, San Antonio, TX, by letters on March 17, 2006. Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C Mex, Mexico, firm initiated recall is ongoing.
PRODUCT: Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5**, Recall # Z-0873-06
REASON: Complaints received regarding difficulty opening the nonadherent layer of the device prior to application to open abdominal wounds.

MANUFACTURER: Dade Behring, Inc, Newark, DE, by letters on April 6, 2006, firm initiated recall is ongoing.
PRODUCT: a) Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic,
Recall # Z-0874-06;
b) Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic,
Recall # Z-0875-06;
c) Stratus CS STAT Fluorometric Analyzer Acute Care c TnI TestPak (CCTNI) in vitro
diagnostic, Recall # Z-0876-06;
d) Stratus CS STAT Fluorometric Analyzer DDMR TestPak (CDDMR) in vitro diagnostic,
Recall # Z-0877-06;
e) Stratus CS STAT Fluorometric Analyzer MYO TestPak (CMYO) in vitro diagnostic,
Recall # Z-0878-06;
f) Stratus CS STAT Fluorometric Analyzer Acute Care pBNP TestPak (CpBNP) in vitro
diagnostic, Recall # Z-0879-06;
g) Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic,
Recall # Z-0880-06;
h) Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic,
Recall # Z-0881-06;
i) Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNI-D) in vitro diagnostic,
Recall # Z-0882-06;
j) Stratus CS STAT Fluorometric Analyzer DDMR DilPak (CDDMR-D) in vitro diagnostic,
Recall # Z-0883-06;
k) Stratus CS STAT Fluorometric Analyzer MYO DilPak (CMYO-D) in vitro diagnostic,
Recall # Z-0884-06;
l) Stratus CS STAT Fluorometric Analyzer Acute Care pBNP DilPak (CpBNP-D) in vitro
diagnostic, Recall # Z-0885-06
REASON: Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.

MANUFACTURER: Recalling Firm: Philips Medical Systems (Cleveland) Inc, Cleveland, OH, by firm representative visit, beginning June 2004, firm initiated recall is ongoing.
PRODUCT: Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images. Software version 1.0 or 1.0.1, Recall # Z-0889-06
REASON: Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.

MANUFACTURER: Bunnell, Inc, Salt Lake City, UT, by letter on April 4, 2005, firm initiated recall is ongoing.
PRODUCT: Life Pulse High Frequency Ventilator (HFV), Recall # Z-0893-06
REASON: Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically.

MANUFACTURER; Recalling Firm: Boston Scientific Target, Fremont, CA, by letters on April 25, 2006. Manufacturer: Boston Scientific, West Valley City, UT, firm initiated recall is ongoing.
PRODUCT: Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F, Catalog #: 1721, Universal Product Number: M00317210, Recall # Z-0895-06
REASON: During forward advancement, the user may experience increased resistance and may exhibit jump-effect, and this could result in increase in procedure time, or vessel injury, including perforation.

MANUFACTURER: Recalling Firm: General Electric Medical Systems LLC, Waukesha, WI, by a validated field action on March 6, 2006. Manufacturer: General Electric Medical Systems, SCS, Bue Cedex, France, firm initiated recall is ongoing.
PRODUCT: a) GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and
Innova 200S mobile version. Cardiovascular Imaging System, Recall # Z-0896-06;
b) GE Healthcare Innova 3100 and Innova 3100 with Bolus Chasing offered as an
option, Cardiovascular Imaging System, Recall # Z-0897-06;
c) GE Healthcare Innova 4100 and Innova 4100 with Bolus Chasing offered as an
option. Digital Fluoroscopic Imaging System, Recall # Z-0898-06
REASON: Incorrect screws were used for mounting the detector, which may lead to a possible part falling onto a patient.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corporation, Indianapolis, IN, by letter dated April 12, 2006. Manufacturer: Roche Diagnostics GmbH, d-68305 Mannheim, Germany. Firm initiated recall is ongoing.
PRODUCT: Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # 1929542 (11929542216). In vitro diagnostic, Recall # Z-0899-06
REASON: A contaminant will change the pH of the R2 bottle, causing deterioration of the enzyme, and resulting in incorrect or no results being reported.

MANUFACTURER: Recalling Firm: Sunrise Medical CCG, Inc. Stevens Point, WI, by letters in January 2006 and April 26, 2006. Manufacturer: Apex Health Care Manufacturer, Inc, Chia Yi Hsien, Taiwan. Firm initiated recall is ongoing.
PRODUCT: Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-HLA-2, HML-400, C-HLA-2T and C-HLA-1, Recall # Z-0904-06
REASON: A field correction is being conducted on select models of Hoyer Patient Lifts because of hydraulic jack problems that have resulted in patient injury. The possibility exists that the mounting stud located in the bottom of the hydraulic jack could become loose allowing the jack to disengage from the mast of the lift.

MANUFACTURER: Recalling Firm: Grifols Biologicals Inc. Los Angeles, CA, by telephone beginning November 11, 2005. Manufacturer: Laboratorios Grifols, S.A.-Spain, Barcelona, Spain. Firm initiated recall is ongoing.
PRODUCT: Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-fill pharmacy compounding system and as a container in the preparation of drug solutions. Gri-bag 500 ml, Recall # Z-0906-06
REASON: When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.

PRODUCT: Low-Boy Bed, AC-powered adjustable hospital bed with a low position of 7" to a high position of 30", Recall # Z-0908-06
MANUFACTURER: Rayes, Inc, dba Wheelchairs of Kansas, Ellis, KS, by visit on/about November 14, 2005 and by service bulletin dated February 28, 2006. Firm initiated recall is ongoing.
REASON: The bed may drop due to a malfunction of the actuator exceeding its stop.

MANUFACTURER: Recalling Firm: Gulf South Medical Supply Inc, Jacksonville, FL, by letter dated April 10, 2006. Manufacturer: TG Medical Sdn Bhd, Selangor, Malaysia. Firm initiated recall is ongoing.
PRODUCT: Powder Free Latex, Non-sterile Medical Exam Gloves, Catalog #'4 22401, 22402, 22403, and 22404, Recall # Z-0909-06
REASON: FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to allow hazardous substances to come into contact with the user's skin.

CLASS III

MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul, MN, by Physician letter, dated October 25, 2005 and by an advisory update, dated December 20, 2005. Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
PRODUCT: a) CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac
Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide.
CONTAK RENEWAL 3 devices provide ventricular tachyarrhythmia and cardiac
resynchronization therapies, Recall # Z-0890-06;
b) CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac
Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide.
CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac
resynchronization therapies, Recall # Z-0891-06;
c) VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable
cardiac defibrillator), Recall # Z-0892-06
REASON: Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.

MANUFACTURER: Beckman Coulter Inc, Fullerton, CA, by letter the week of March 15, 2006. Manufacturer: Beckman Coulter, Inc., Brea, CA. Firm initiated recall is ongoing.
PRODUCT: a) SYNCHRON LX 20, SYNCHRON LX 20 PROClinical Systems; Operating Software
Version 4.5; Part Number: A23724 In vitro diagnostic, Recall # Z-0900-06;
b) SYNCHRON LX i 725 Clinical Systems; Operating Software Version 4.5; Part
Number: A23724, Recall # Z-0901-06;
c) Unicel DxC 600/800 SYNCHRON Clinical Systems; Operating Software Version 1.0
and 1.2; Part Number: A20463 and A27331, Recall # Z-0902-06
REASON: It was confirmed that the ORDAC (Over Range Detection And Correction) feature (auto & manual) does not perform correctly for the glucose cup chemistry (GLUCm) when sample type of 'Other' is selected w/operating software version 4.5. Results for these samples could be elevated as much as twice the actual value. The ORDAC feature does function properly w/serum, plasma, urine & CSF.

MANUFACTURER: Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN, by letter beginning on November 22, 2005, firm initiated recall is ongoing.
PRODUCT: Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy, Recall # Z-0905-06
REASON: A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. This anomaly does not affect patient safety. This anomaly can be corrected by reprogramming the Restore Neurostimulator using specific software.

If you require further information, please call.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 24, 2006:

CLASS II

MANUFACTURER: General Electric Med Systems LLC, Waukesha, WI, by Urgent Safety Notification beginning September 1, 2005, firm initiated recall is ongoing.
PRODUCT: GE Signa Advantage nuclear magnetic resonance imaging system, Recall # Z-0858-06
REASON: During use of GE Signa nuclear magnetic resonance imaging system, a flexible Teflon tube that was part of the magnet vent system ruptured and allowed the magnet to vent into the scan room. Because of helium pressure inside the room, the scan room door could not be reopened after the patient was removed from the scan room.

MANUFACTURER: Valleylab, Boulder, CO, by telephone and fax on April 21, 2006, firm initiated recall is ongoing.
PRODUCT: Cool-tip RF Generator, for use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue. Product Number: CTRF117 and CTRF220, Recall # Z-0859-06
REASON: Electrosurgical ablation device may experience loss of power during use, when used with Cool-tip Switching controller in ablation mode.

MANUFACTURER: Recalling Firm: Konica Minolta Medical Imaging USA, Inc., Wayne, NJ, by telephone on February 6, 2006, followed with a fax, e-mail and letter.
Manufacturer: Konica Minolta Medical & Graphic, Inc., Tokyo, Japan, firm initiated recall is ongoing.
PRODUCT: REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. The Konica REGIUS Image Manager Software (RIM) is used to receive and manage computerized X-Ray image file workflow, Recall # Z-0862-06
REASON: If the patient demographic data is entered into the CS-1 manually, and the user fails to enter any data in one of the demographic data fields labeled as Birthday, Sex, Name or Patient Comments, etc, the RIM will populate the fields where no data has been entered with data from the previous patient.

MANUFACTURER: Recalling Firm: Kimberly-Clark Corporation, Roswell, GA, by fax on/about March 15, 2006. Manufacturer: Ballard Medical Products, Draper, UT, firm initiated recall is ongoing.
PRODUCT: a) Kimberly Clark * 20' Minibore Extension Line * Single Use * Sterile * Rx only *
This is a Pain Management Product that is sold in a wide variety of kits including both
standard tray configurations and custom kits, Product Code: 18938,
Recall # Z-0864-06;
b) Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only *,
Product Code: 18146, Recall # Z-0865-06;
c) Kimberly Clark * Nerve Block Tray * Single Use * Sterile * Rx only * Product
Code: 18164, Product Code: 181027, Product Code: 181A040, Product Code:
181A108, Product Code: 181A144, Product Code: 181A170, Recall # Z-0866-06;
d) Kimberly Clark * Nerve Root Block Tray * Single Use * Sterile * Rx only *,
Product Code: 181236, Recall #Z-0867-06;
e) Kimberly Clark * Selective Nerve Block Tray * Single Use * Sterile * Rx only *,
Product Code: 181A236, Recall # Z-0868-06;
f) Kimberly Clark * Universal Block Tray * Single Use * Sterile * Rx only *,
Product Code: 181000, Product Code: 181053, Product Code: 181066,
Product Code: 181069, Product Code: 181126, Product Code: 181128, Product Code:
181167, Product Code: 181253, Product Code: 181255, Product Code: 181269,
Product Code: 181A055, Product Code: 181A088, and Product Code: 181A237,
Recall # Z-0869-06
REASON: The Pain Management Procedural Trays may contain extension sets that do not meet USP specification requirements for non pyrogenicity (less than or equal to 2.25 EU/device (Endotoxin Units/device).

MANUFACTURER: Excelsior Medical Corp, Neptune, NJ, by letter on March 22, 2006. Firm initiated recall is ongoing.
PRODUCT: ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, Recall # Z-0870-06
REASON: Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode with a 60cc syringe or smaller.

MANUFACTURER: Hollister Stier Laboratories LLC, Spokane, WA, by letter on April 20, 2006, firm initiated recall is ongoing.
PRODUCT: Sterile empty vials, 10mL/20mm closure sold 25/case. Labels on case states CAUTION: For manufacturing, Processing or Repacking Rx only NON_RETURNABLE LOT, Recall # Z-0871-06
REASON: Potential for vials to be cracked at the vial stopper interface. This could compromise the sterility of the products compounded into the vials.

MANUFACTURER: Pioneer Surgical Technology, Marquette, MI, by letters dated March 3, 2006 and March 10, 2006, firm initiated recall is ongoing.
PRODUCT: Zimmer Cannulated Screw System Cannulated Driver, 5.0 mm Hex, REF 1147-49-50; Catalog # 00-1147-049-50, Recall # Z-0872-06
REASON: There may be an obstruction in the cannula that will prevent the guide wire from passing through it. The obstruction in the cannula can force the guide wire to advance further into the patient than intended.

MANUFACTURER: Beckman Coulter, Inc, Brea, CA, by letter on March 30, 2006, firm initiated recall is ongoing.
PRODUCT: SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824, Recall # Z-0886-06
REASON: Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M11327. Internal QC recovery was as much as 15% lower than the assigned target value.

CLASS III

MANUFACTURER: Recalling Firm: Guidant Corporation, St. Paul, MN, by press release on March 13, 2006 and by letter dated May 11, 2006. Manufacturer: Guidant-Ireland, Clomel, Ireland, firm initiated recall is ongoing.
PRODUCT: CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricualar tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with suden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. The device also uses accelerometer-based adaptive-rate bradycardia therapy. These CONTAK RENEWAL RF devices feature enhanced telemetry communication with wandless ZIP telemetry. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform, Recall # Z-0683-6
REASON: Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.

If you require further information, please call.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 17, 2006:

CLASS II

MANUFACTURER: Eagle Vision, Inc., Memphis, TN, by letters beginning on April 12, 2006 and a second notice dated April 19, 2006. Firm initiated recall is ongoing.
PRODUCT: a) Krupin Eye Valve, P/N 6003, Recall # Z-0844-06;
b) Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V, Recall # Z-0845-06;
c) Glaucoma Aqueous Shunt, 365 mm, valved, P/N EG365V, Recall # Z-0846-06;
d) Valve-EV Glaucoma Ultra-Smooth, P/N 6006, Recall # Z-0847-06
REASON: Products may have deformed valves which would cause the valve not to close within the specified pressure tolerances.

MANUFACTURER: Recalling Firm: Medtronic Neurosurgery, Goleta, CA, by letter and fax on March 8, 2006. Manufacturer: Antrin Enterprises, Inc, Ojai, CA. Firm initiated recall is ongoing.
PRODUCT: Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215, The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm's TiMesh System. The product is sold in non-sterile, single unit packages. They are re-usable, and autoclavable. Recall # Z-0849-06
REASON: Medtronic Neurosurgery has initiated this action because it was determined that two lots of the Modular Screwdriver Blade components may exhibit burrs along the tips of the Screwdriver, which may prevent adequate engagement with the associated screws.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on April 6, 2006. Manufacturer: Philips Medical Systems, Best, Netherlands. Firm initiated recall is ongoing.
PRODUCT: a) MD3 X-ray system, Recall # Z-0851-06;
b) MD4 X-ray system, Recall # Z-0852-06
REASON: Potential for unexpected table movement

MANUFACTURER: Recalling Firm: General Electric Medical Systems LLC, Waukesha, WI, by letter dated October 8, 2004. Manufacturer: General Electric Medical Systems, SCS, Bue Cedex, France. Firm initiated recall is complete.
PRODUCT: Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software (Version 4.0, 4.1, or 4.2), Recall # Z-0854-06
REASON: Display in fused mode- viewer allows 2 studies ( PET/CT) registered in the same spatial domain to be viewed simultaneously. These 2 images should be visually aligned to a precision of less than 1/2 PET Voxel. A problem associated with this version of software may introduce a shift of up to 1.5 PET Voxels, which can be as much as 8 mm with certain zoom factors.

MANUFACTURER: Recalling Firm: AGFA Corporation, Greenville, SC, by visit at the time of upgrading on November 3, 2005, December 19, 2005 and December 28, 2005.
Manufacturer: AGFA, Mortsel, Belgium. Firm initiated recall is complete.
PRODUCT: CR DX-S, DX-S, Computed radiography system (Digitizer), Software versions: STR1102B and below, Recall # Z-0855-06
REASON: Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop.

MANUFACTURER: Recalling Firm: B K Medical Systems, Inc, Wilmington, MA, by letter on April 10, 2006. Manufacturer: B-K Medical A/S, Herlev, Denmark. Firm initiated recall is ongoing.
PRODUCT: Convex Array Transducer used with B-K Ultrasound Scanners, Model number: 8667, Recall # Z-0856-06
REASON: Due to a problem with calibration, the device can produce up to 50% elevated acoustic output and up to 2 degrees higher surface temperature.

MANUFACTURER: GE Healthcare, Madison, WI, by letter dated November 16, 2005. Firm initiated recall is ongoing.
PRODUCT: Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU), Recall # Z-0857-06
REASON: Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or disappear as a result of normal handling of the anesthesia machine. Visual alarms on the ADU are unaffected by this condition. The dampening or absence of audible alarms on the ADU may result in a delay in treatment.

CLASS III

MANUFACTURER: Recalling Firm: Celsion Corporation, Inc, Columbia, MD, by letters on February 17, 2006 and March 22, 2006. Manufacturer: Accellent Juarez, Inc, Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
PRODUCT: Prolieve™ Thermodilatation® Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, Material Number M0068808023, Recall # Z-0843-06
REASON: Surgical treatment kits containing medical device components were mislabeled with extended expiration dates.

MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by letter on/about April 21, 2006. Firm initiated recall is ongoing.
PRODUCT: Cook Esophageal Dilator Set ------- Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook® *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook® * Recall # Z-0848-06
REASON: Large product label contains an incorrect expiration date.

MANUFACTURER: Kamiya Biomedical Company, Seattle, WA, by telephone on April 11, 2006 and April 17, 2006. Firm initiated recall is complete.
PRODUCT: K-ASSAY CRP (2) Reagent. Kit is labeled K-ASSAY CRP (2) Latex Particle Enhance ITA. Kit contains 2 vials. One vial labeled K-ASSAY CRP (2) R-1 30 mL 170 mM Glycine Buffer, via has a white cap. The other vial labeled K-ASSAY CRP (2) R-2 20 mL Latex Suspension human CRP rabbit antibodies, vial has a red cap. Recall # Z-0850-06
REASON: Kits may contain 2 vials of the same reagent instead of 1 vial of buffer reagent and 1 vial of antibody reagent.

MANUFACTURER: Affymetrix, Inc, Bedford, MA, by email dated April 14, 2005 and by letter on December 28, 2005. Firm initiated recall is ongoing.
PRODUCT: Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software, Recall # Z-0853-06
REASON: Incorrect software version of instrument controller is not compatible with new configuration. This incorrect configuration may cause the instrument system to fail at start-up or during a run.

If you require further information, please call.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 10, 2006:

CLASS I

MANUFACTURER: Respironics California Inc., Carlsbad, CA, by letters on March 20, 2006. Firm initiated recall is ongoing.
PRODUCT: Ventilator-PLV Continuum (PLVC I), Model Number: P1000. The PLVC I is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. It utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The PLVC I user interface has a membrane keypad with indicator Light Emitting Diodes for the selection and acceptance of patient settings and for the display of alarm conditions. PLVC I provides the following types of ventilatory support: 1) Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece ). 2) Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV)or Continuous Positive Airway Pressure (CPAP) modes of ventilation. 3) Volume-Controlled (VC). Available in AlC and SIMV. 4) Pressure-Controlled (PC). Available in AlC and SIMV. 5) Pressure Support (PS). Available in SIMV and SPONT, Recall # Z-0808-6
REASON: Flow valve failures- When failure occurs, air flow from the ventilator ceases resulting in the PLVC I transitioning into a 'Vent Inop' mode whereby the safety valve is activated, opening the circuit to ambient air. Ventilator dependent patients may not receive adequate ventilatory support if this problem occurs.

CLASS II

MANUFACTURER: Haemonetics Corporation, Braintree, MA, by letter on December 21, 2005. Firm initiated recall is ongoing.
PRODUCT: a) Haemonetics Cell Saver 5 Autologous Blood Recovery System Model Numbr: LN02005-110-E. Recall # Z-0822-6; b) Haemonetics Cell Saver 5+ Autologous Blood Recovery System
Model Number: LN02005-110EP, Recall # Z-0823-06
REASON; Device emits radiofrequency which exceeds the IEC 60601-1-2 International Standard

MANUFACTURER: Hobbs Medical, Inc., Stafford Springs, CT, by letter on March 15, 2006. Firm initiated recall is ongoing.
PRODUCT: Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to remove foreign object or cauterize polyp specimens from the GI tract. REF: 5030 and 5030S, Recall # Z-0824-06
REASON: Diameter of device at the distal end would prevent it from passing through the endoscope's working channel.

MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul, MN, by visit on April 10-12, 2006, and by letters April 11-14, 2006. Manufacturer: Guidant-Ireland, Clomel, Ireland, firm initiated recall is ongoing.
PRODUCT: a) Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE
(models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Sterile EO. Cardiac resynchronization therapy defibrillators (CRT-D) provide
ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular
tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and
ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death
(SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and
uses biventricular electrical stimulation to synchronize ventricular contractions.
Cardioversion/defibrillation therapies include a range of low-and high-energy shocks
using either a biphasic or monophasic waveform, Recall # Z-0825-06;
b) Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE
(model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO.
Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular
tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia
therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation
(VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac
resynchronization therapy is for the treatment of heart failure (HF) and uses
biventricular electrical stimulation to synchronize ventricular contractions.
Cardioversion/defibrillation therapies include a range of low-and high-energy shocks
using either a biphasic or monophasic waveform, Recall # Z-0826-06;
c) Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization
Therapy Defibrillator (CRT-D). Sterile EO. Cardiac resynchronization therapy
defibrillators (CRT-D) provide both atrial and ventricular tachyarrhythmia and cardiac
resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment
of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are
associated with sudden cardiac death (SCD). Atrial tachyarrhythmia therapy is for the
treatment of supraventricular tachycardia (SVT) and atrial fibrillation (AF). Cardiac
resynchronization therapy is for the treatment of heart failure (HF) and uses
biventricular electrical stimulation to synchronize ventricular contractions. This device
also uses accelerometer-based adaptive-rate bradycardia therapy.
Cardioversion/defibrillation therapies include a range of low-and high-energy shocks
using either a biphasic or monophasic waveform, Recall # Z-0827-06;
d) Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile
EO. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The device offers dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), Recall # Z-0828-06
REASON: 77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.

MANUFACTURER: Recalling Firm: Medtronic Gastroenterology/Urology, Shoreview, MN, by letter on January 25, 2006. Manufacturer: Catheter & Disposal Technology, Plymouth, MN, firm initiated recall is ongoing.
PRODUCT: Medtronic Zinetics 24ME Multi-Use External Reference pH Catheter. For Gastroesophageal pH Measurements. Catalog number 9012P2121, Recall # Z-0830-06
REASON: Lot 0001491 has a manufacturing defect in the sensor spacing. Sensors have been placed 5 cm apart instead of 15 cm apart. Medtronic has determined that patient safety is not compromised. Clinicians however should review and reassess the results of any patient studies for which catheters from lot 0001491 were used.

MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated March 29, 2006. Manufacturer: Baxter Healthcare Corporation, Largo, FL, firm initiated recall is ongoing.
PRODUCT: a) RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software, Recall # Z-0831-06;b) RenalSoft v.1.1 - PD Module; clinical data management software, Recall # Z-0832-06; c) Renal Software Suite v.3.1 - HD Module; clinical data management software, Recall # Z-0833-06
REASON; There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.

MANUFACTURER: Recalling Firm: Fresenius Medical Care North America, Lexington, MA, by telephone on March 24, 2006 and letter dated March 30, 2006.
Manufacturer: Erika De Reynosa S. A. de C. V., Reynosa, Tamps, Mexico. Firm initiated recall is ongoing.
PRODUCT: Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. Catalog Number: 050-87028, Recall # Z-0834-06
REASON: Stay safe trigger body may not connect to the extension set and result in associated peritonitis

MANUFACTURER: Recalling Firm: Bard Access Systems, Inc., Salt Lake City, UT, by letter on April 6, 2006. Manufacturer: Bard Medical, Nogales, Sonora, Mexico. Firm initiated recall is ongoing.
PRODUCT: a) 18F Tri-Funnel Replacement Gastrostomy Tube, Product Code 000718, Recall # Z-0836-06;
b) 20F Tri-Funnel Replacement Gastrostomy Tube, Product Code 000720, Recall # Z-0837-06;c) 22F Tri-Funnel Replacement Gastrostomy Tube, Product Code 000722, Recall # Z-0838-06;d) 24F Tri-Funnel Replacement Gastrostomy Tube, Product Code 000724 Recall # Z-0839-06
REASON: Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection.

MANUFACTURER: Southwest Technologies, Inc., N. Kansas City, MO, by letters on March 27, 2006. Firm initiated recall is ongoing.
PRODUCT: Elasto-Gel Wound Dressings, 3 product codes: Elasto-Gel Plus, Product DR8050, Elasto-Gel, DR 8000, and Elasto-Gel, DR 8000LV (for foreign distribution only), 4'' x 4'', Sterile, each package contains 1 wound dressing, 5 packages per intermediate box, 20 intermediate boxes (100 pkgs) per case, Recall # Z-0841-06
REASON: The product is labeled as sterile and one of the lots failed sterility during the quarterly radiation dose audit.

MANUFACTURER: Candela Laser Corporation, Wayland, MA, by email on January 17, 2006, firm initiated recall is complete.
PRODUCT: Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300, Recall # Z-0842-06
REASON: Handle fires even when the finger is off the switch.

CLASS III

MANUFACTURER: Ev3, Inc, Plymouth, MN, by a Field Action Form on December 29, 2005. Firm initiated recall is ongoing.
PRODUCT: IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is intended as a permanently implanted device. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is designed to be crimped onto a non-compliant PTA balloon catheter that is indicated for biliary stent expansion. After mounting onto a balloon catheter, it is deployed and expanded by inflating the balloon. Model S15-36, Recall # Z-0829-06
REASON; IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001). The stent is 10 mm longer than labeled.

MANUFACTURER: Thera Test Laboratories, Inc., Lombard, IL, by telephone on October 26, 2005, and between January 4-9, 2006, and by letters dated January 9, 2006. Firm initiated recall is complete.
PRODUCT: EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit, Catalog #201-204, Recall # Z-0835-06
REASON; The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204.

MANUFACTURER: Straumann Manufacturing, Inc, Andover, MA, by letter dated March 30, 2006. Straumann Ag Inst, Basel, Switzerland. Firm initiated recall is ongoing.
PRODUCT: Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043, Recall # Z-0840-06
REASON: The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top.

If you require further information, please call.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 5, 2006.

CLASS II
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters dated October 27, 2005. Manufacturer: Baxter Healthcare Corp, Singapore, Singapore, firm initiated recall is ongoing.
PRODUCT: a) Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Recall # Z-0549-06;b) Baxter AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W, Recall # Z-0550-06
REASON: When infusing at flow rates below 0.5 mL/hr, the upstream occlusion alarm of the pumps may not detect the occlusion.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters dated December 21, 2005. Manufacturer: Baxter Healthcare Corp, Singapore, Singapore, firm initiated recall is ongoing.
PRODUCT: a) Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Recall # Z-0551-06; b) Baxter AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W, Recall # Z-0552-06; c) Baxter OCA II Syringe Infusion Pump, product codes 2L3104 and 2L3104R
REASON: Delivery of unrequested PCA doses of medication due to damaged PCA cords, partial sticking of PCA button, and fluid ingress into the pump or PCA button.

MANUFACTURER: Recalling Firm: Liko, Inc, Franklin, MA, by letter on January 9, 2006. Manufacturer: Liko AB, Lulea, Sweden, firm initiated recall is ongoing.
PRODUCT: a) Liko Universal Slingbar 450 aluminum, used with the Viking M Patient Lift, Recall # Z-0790-06; b) Liko Universal Slingbar 450 aluminum, used with the Viking L Patient Lift, Recall # Z-0791-06
REASON: The swivel adapter which is mounted directly above the slingbar's split center bolt could be removed and allow the slingbar to be improperly mounted directly into the aluminum link arm. This could cause an unsafe transfer. Patient may fall.

MANUFACTURER: Recalling Firm: Synthes USA, West Chester, PA, by telephone March 31, 2006 through April 3, 2006 and by letter on April 3, 2006. Manufacturer: Synthes GmbH, Switzerland, firm initiated recall is ongoing.
PRODUCT: Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton, Recall # Z-0792-06
REASON: Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter on March 9, 2006. Manufacturer: Seimens Medical Solutions, Forchheim, Germany, firm initiated recall is ongoing.
PRODUCT: a) Somatom CT System Emotion 16, model number 7734713. Computed tomography x-ray system,
Recall # Z-0793-06;
b) Somatom CT System Emotion 16, model number 7393114. Computed tomography x-ray system,
Recall # Z-0794-06;
c) Somatom CT System Sensation 40, model number 8874427 and Sensation 64, model number 8377520. Computed tomography x-ray system,
Recall # Z-0795-06;
d) Somatom CT System Sensation Open, model number 8872017. Computed tomography x-ray system,
Recall # Z-0796-06;
REASON: When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter on March 28, 2006. Siemens Medical Solutions, Forchheim, Germany, firm initiated recall is ongoing.PRODUCT: Somatom Sensation CT Systems, Sensation 10, model number 7543015,
Sensation 16, model number 7393114, Sensation 64, model number 8377520, and Sensation Open model number 8872017, Recall # Z-0797-06
REASON: Firm became aware of a potential problem that could affect scan results and require patient exam to be repeated when using the customized ECG-gated scan protocols in the CT2006A and CT2006G software of their SOMAtOM Sensation CT Systems.

MANUFACTURER: Recalling Firm: Smith & Nephew, Andover, MA, by letter dated March 24, 2006. Manufacturer: Smith & Nephew, Inc, Endoscopy Division, Mansfield, MA, firm initiated recall is ongoing.
PRODUCT: FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399, Recall #0798-06
REASON; The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.

MANUFACTURER: Smiths Medical MD, Inc, Saint Paul, MN, by letter dated March 29, 2006, firm initiated recall is ongoing
PRODUCT: a) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4653-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wandcover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use, Re-order number 21-4653-24, Recall # Z-0800-06; b) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. tray. REF 21-4655-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 16G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 8.5 Fr Introducer, ''J'' Guidewire, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Re-order Number 21-4655-24, Recall # Z-0801-06; c) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4672-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO Sterilized. Single Use. Re-order Number 21-4672-24, Recall # Z-0802-06; d) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4673-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J'' Guidewires, 2 Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Re-order number 21-4673-24, Recall # Z-0803-06; e) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J'' Guidewires, Syringes, VeinPick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-LokSharps Safety Devices, Product Information. EtO Sterilized. Single Use. Re-order number 21-4683-24, Recall # Z-0804-06; f) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. tray. REF 21-4685-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 16G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 8.5 Fr Introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Re-order number 21-4685-24, Recall # Z-0805-06; g) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4690-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO Sterilized. Single Use. Re-order number 21-4690-24, Recall # Z-0806-06;h) Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Dual-lumen Fluoro-Free Venous Access System, Dual Lumen Silicone Catheter, 3.4mm O.D. tray. REF 21-8652-24. Contents: Dual-lumen Portal with WING-LOCK Connector, Radiopaque Dual-lumen PolyFlow Polyurethane Catheter, 10.2 Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, 2 GRIPPER PLUS Non-Coring Safety needles 20G, 20G 90-degree PORT-A-CATH needle, 18G Extra Thin Wall Introducer Needle, 11 Fr Introducer, ''J'' Guidewire, Syringes, Tunneling Tool, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Re-order number 21-8652-24, Recall # Z-0807-06
REASON: One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised. The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems. The packaged Wand-Cover is placed on the outside of the PORT-A-CATH II AND P.A.S. PORT tray.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter on March 10, 2006. Manufacturer: Siemens Medical Solutions, Forchheim, Germany, firm initiated recall is ongoing.PRODUCT: AXIOM Artis X-ray systems running software versions VB11K and VB22-G, AXIOM Artis FC model number 5904433, AXIOM Artis BC model number 5904649, AXIOM Artis MP model number 5904466, AXIOM Artis FA model number 5904441, AXIOM Artis BA model number 5904656, AXIOM Artis TC model number 7728350, AXIOM Artis TA model number 7007755, AXIOM Artis dFC model number 7412807, AXIOM Artis dFC-MN model number 7727717, AXIOM Artis dBC model number 7728392, AXIOM Artis dTC model number 7413078, AXIOM Artis dFA model number 7555373, AXIOM Artis dBA model number 7555357, AXIOM Artis dTA model number 7008605, AXIOM Artis dMP model number 7555365.Recall # Z-0809-06;
REASON: The recalling firm became aware of a potential problem when imaging patients on their stomach on the AXIOM Artis X-ray Systems running software versions VB11K and VB22G. In some instances, the orientation labels could be incorrect.

MANUFACTURER: Macan Engineering and Manufacturing Co, Inc, Chicago, IL, by letters dated March 23, 2006 and April 5, 2006. Firm initiated recall is ongoing.
PRODUCT: Macan Model MC-4A Dental Electrosurgical Unit, Recall # Z-0810-06
REASON: The product label fails to warn users to use the device on patients with shielded pacemakers only.

MANUFACTURER: Medex, Inc, Dublin, OH, by letter dated November 11, 2005, firm initiated recall is ongoing.
PRODUCT: MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE'', Recall # Z-0811-06
REASON: The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex.

MANUFACTURER: Medex, Inc, Dublin, OH, by letter dated November 18, 2005, firm initiated recall is ongoing.
PRODUCT: MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product is labeled on the outer case with a stick-on label that reads in part, ''**STERILE***MX441B CVP Manometer**Lot#***Latex Free'', Recall # Z-0812-06
REASON: The product is labeled as 'Latex Free' , however,one of the components of the finished product may contain latex.

MANUFACTURER: Alpha Omega Services, Inc, Bellflower, CA, by letters beginning February 22, 2006, firm initiated recall is ongoing/
PRODUCT: a) TII0002 Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable, Recall # Z-0813-06;b) VariSource AL 13199023 Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons: 20/PKG, Recall # Z-0814-06;c) TIT0001-003, Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons,Recall # Z-0815-06;d) VariSource AL 13199024, Implant Tube, Implant Tube, Intralumenal(HDR),
10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable,Recall # Z-0816-06; e) KCV0008-001, AOS Intralumenal Kit: Intralumenal Implant Tubes (5EA),Recall # Z-0817-06;f) VariSource AL 13197000, Tongue/Soft Tissue Kit, Recall # Z-0818-06; g) KTV0006-002, AOS Tongue And Soft Tissue Kit: AOS Tngue And Soft Tissue Inplant Tubes (20EA); 20CM S.S. Implant Needles, 14 Degrees (20EA), Recall # Z-0819-06; h) VariSource AL13198000, Intralumenal Kit, Recall # Z-0820-06
REASON: There is a possibility that the diameter of the catheter does not meet specifications. As a result it may not be possible to correctly connect the catheter to a VariSource Quick Connect. This would prevent any treatment. Furthermore, since the problem would not be apparent until after the catheter has been implanted an unnecessary surgical implantation procedure would have taken place.

MANUFACTURER: LMS Medical Systems Ltd, Montreal, Canada, by telephone on January 11, 2005 and by email or fax on/about January 13, 2005, firm initiated recall is complete.
PRODUCT: CALM software. This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions, Recall # Z-0821-06
REASON: A deficiency in the software code can, in certain circumstances, cause data for the wrong patient to be displayed in the Tracing Review screen when a user is acknowledging an Alert.

CLASS III
MANUFACTURER: Encore Medical, Lp, Austin, TX, by letters on January 12, 2006 and January 30, 2006. Firm initiated recall is ongoing.
PRODUCT: Keramos Ceramic-on-Ceramic Acetabular System, Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component, Recall # Z-0799-06
REASON: Voids in the porous coating of a component used in total hip replacement surgery.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 26, 2006

CLASS I

MANUFACTURER: Blackstone Medical, Inc., Springfield, MA, by email on December 23, 2005 and by letter on December 28, 2005, firm initiated recall is ongoing.

PRODUCT: ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092, Recall # Z-0716-06

REASON: Pedicle Screw may disengage in post operative period requiring intervention.

MANUFACTURER: Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated March 28, 2006 and by press release on March 31, 2006.

Manufacturer: Ortho-Clinical Diagnostics, Cardiff, UK, firm initiated recall is ongoing.

PRODUCT: VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy, Recall # Z-0765-06

REASON: Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immunodiagnostic ECi/ECiQ laboratory system, and when used may produce inaccurate test results in some cases.

CLASS II

*****CORRECTION***** I

n the April 12, 2006 Enforcement Report the serial numbers listed for recall # Z-0710-06 (Lifepak 12) are the serial numbers for recall Z-0711-06 (Lifepak 20). See correct Codes below: RECALLING FIRM/MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters dated March 2006, firm initiated recall is ongoing.

PRODUCT: a) Lifepak 12 defibrillator/monitor, Recall # Z-0710-06; b) Lifepak 20 defibrillator/monitor, Recall # Z-0711-06

REASON: Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.

******RECALL EXTENSION******

MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated February 8, 2006 and by letter dated February 27, 2006 when the recall was extended to the two additional products. Firm initiated recall is ongoing.

PRODUCT: a) Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number 00-7712-035-01, Recall # Z-0671-06; b) Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; Part number 00-7712-035-02, Recall # Z-0672-06; c) Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product, Recall # Z-0770-06; d) Zimmer M/L Taper Rasp Handle, Right, 45 degrees, non-sterile; Part number 83-7712-035-02. Recall Z-0671-06 extended to include this product, Recall # Z-0771-06

REASON: A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corporation, Mc Gaw Park, IL, by letters dated February 24, 2006.

Manufacturer: Baxter Healthcare Corporation, Largo, FL, firm initiated recall is ongoing.

PRODUCT: System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3D, SYS1000L32C2, SYS1000L3TD, SYS1000LC2, Recall # Z-0766-06

REASON: The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts become cracked during patient treatment, there is the potential for an ultrafiltration error to occur, which can result in excessive removal of fluid from the patient.

MANUFACTURER: Recalling Firm: Smiths Medical ASD, Inc., Rockland, MA, by letter dated March 8, 2005.

Manufacturer: Smiths Healthcare Manufacturing S.A. de C.V., Tijuana, Mexico, firm initiated recall is ongoing.

PRODUCT: a) STS-400 Levell® Skin Temperature Sensor with 400 Series Thermistor, Recall # Z-0767-06; b) TTS-400J Levell® Tympanic Temperature Sensor with 400 Series Thermistor, Recall # Z-0768-06

REASON: Product temperature readings may be 2ºC higher than the actual temperature.

MANUFACTURER: Recalling Firm: Karl Storz Endoscopy America Inc, Culver City, CA, by letter on March 10, 2006. Manufacturer: Omni Corp., Livonia, MI, firm initiated recall is ongoing.

PRODUCT: Storz Documentation Cart with Articulating Arm, Model Number 9601F, Recall # Z-0769-06

REASON: The articulating arm on the cart, which holds the monitor, may fall off from the cart during manipulation. When it falls, it could hit the ground or fall on the people/objects that are in close proximity.

MANUFACTURER: Recalling Firm: Valleylab, Boulder, CO, by letter on January 27, 2006.

Manufacturer: United States Surgical Corporation, North Haven, CT, firm initiated recall is ongoing.

PRODUCT: a) LigaSure Atlas Laparoscopic Vessel Sealer/Divider, Catalog Number LS1100, Recall # Z-0772-06; b) LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider, Catalog Number LS1120, Recall # Z-0773-06

REASON: Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 4, 2006. Manufacturer: Precision Systems, Chiba, Japan, firm initiated recall is ongoing.

PRODUCT: a) MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001, Recall # Z-0774-06; b) MagNA Pure LC DNA Isolation Kit - Large Volume; Catalog number 03310515001, Recall # Z-0775-06; c) MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 03264793001, Recall # Z-0776-06

REASON: The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.

MANUFACTURER: Recalling Firm: Medline Industries, Inc. Waukegan, IL, by visit on March 30, 2006. Manufacturer: Master & Frank Enterprise Co. Ltd, Kuantung, China, firm initiated recall is complete.

PRODUCT: Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case, Recall # Z-0777-06

REASON: The product may not be sterile. The pouches were damaged during sterilization.

MANUFACTURER: Megadyne Medical Products, Inc, Draper, UT, by letter on April 6, 2006, firm initiated recall is ongoing.

PRODUCT: a) Rocker Switch Electrosurgical Pencil with E-Z Clean Tip, Catalog Number 0030H, Recall # Z-0778-06; b) Button Switch Electrosurgical Pencil with E-Z Clean Tip and Holster, Catalog Number 0035H, Recall # Z-0779-06; c) Rocker Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster, Catalog Number 0036H, Recall # Z-0780-06; d) Button Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster, Catalog Number 0037H, Recall # Z-0781-06; e) Rocker Switch Electrosurgical Pencil with Stainless Steel Tip and Holster, Catalog Number 0038H, Recall # Z-0782-06; f) Button Switch Electrosurgical Pencil with Stainless Steel Tip and Holster, Catalog Number 0039H, Recall # Z-0783-06; g) Rocker Switch Electrosurgical Pencil with Holster, Catalog Number 3030HT, Recall # Z-0784-06; h) Button Switch Electrosurgical Pencil with Holster, Catalog Number 3035HT, Recall # Z-0785-06

REASON: Surgical device packaging may be damaged and may compromise sterility.

MANUFACTURER: Boston Scientific Target, Fremont, CA, by letters on March 6, and March 21, 2006, firm initiated recall is ongoing.

PRODUCT: ILab Utrasound Imaging System, software controlled Imaging Catheter, Model Numbers M0004EPiL120CART0, H749iLab120CART0, H749iLab120CARTD0, H749iLab120CARTR0, H749iLab120INS0, Recall # Z-0789-06

REASON: Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only).

CLASS III

MANUFACTURER: Recalling Firm: Remel, Inc. Lenexa, KS, by letter dated February 14, 2006, firm initiated recall is complete.

PRODUCT: Oxoid Infectious Mononucleosis Test, Catalog # DR0680M, Recall # Z-0786-06

REASON: Some units exhibit weak false-positive reactions with some negative patient serum.

MANUFACTURER: BEC Laboratories, Inc., Toledo, OH, by fax on March 29, 2006, firm initiated recall is ongoing.

PRODUCT: Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The product labeling reads as follows: "b.e.c. Growth-Chek Microbial Suspensions/Aspergillus niger Derived from ATCC Culture #16404**** Store Under Refrigeration***10mL *Shake Well", Recall # Z-0787-06

REASON: Aspergillus niger microbial suspension, found to be contaminated with yeast,

MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by letter on/about February 16, 2006. Manufacturer: AGFA Corp., Goose Creek, SC, firm initiated recall is ongoing.

PRODUCT: Mamoray™ HDR-C PLUS Mammography film, Recall # Z-0788-06

REASON: The film was incorrectly notched.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 19, 2006

CLASS I

This is an extension of Class I recall # Z-0524/0526-06, reported in the March 1, 2006, Enforcement Report:

MANUFACTURER: Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Cranston, RI, by letters on December 22, 2005, December 27, 2005, January 5, 2006 and March 24, 2006 Manufacturer: Bard, Las Piedras, PR, firm initiated recall is ongoing.

PRODUCT: a) Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7" x 10.7" Code: 0010206, Recall # Z-0524-06; b) Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8" x 13.7" (25.4cm x 33cm) Code: 0010207, Recall # Z-0525-06; c) Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7" x 9.7" (19.6cm x 24.6cm) Code: 0010208, Recall # Z-0526-06; d) Bard® Composix® Kugel Large Oval, 5.4" x 7" for hernia repairs Product Code: 0010202, Recall # Z-0760-06; e) Bard® Composix® Kugel Large Circle, 4.5" for hernia repairs Product Code: 0010204, Recall # Z-0761-06; f) Bard® Composix® Kugel Oval, 6.3 x 12.3"' for hernia repairs Product Code: 0010209, Recall # Z-0762-06

REASON: Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Z-0760/0762-06 extension of recall Z-0524/0526-06)

CLASS II

MANUFACTURER: Rubicor Medical, Inc., Redwood City, CA, by visit on February 17, 2006 and by letter, dated March 13, 2006, firm initiated recall is complete.

PRODUCT: Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Recall # Z-0715-06

REASON: Devices’ sterility may be compromised due to lack of adequate sterilization.

MANUFACTURER: Recalling Firm: Respironics, Inc., Murrysville, PA, by letter, telephone and e-mail on January 3, 2006. Manufacturer: Caradyne Ltd., Galway, Ireland, firm initiated recall is ongoing.

PRODUCT: NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous), Recall # Z-0717-06

REASON: Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.

MANUFACTURER: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter dated January 25, 2006, firm initiated recall is ongoing.

PRODUCT: a) METRx II Tube, 14mm x 3cm stainless steel tubular retractor, Part No. 9569660, Recall # Z-0719-06; b) METRx II Tube, 14mm x 4cm stainless steel tubular retractor, Part No. 9569661, Recall # Z-0720-06; c) METRx II Tube, 14mm x 5cm stainless steel tubular retractor, Part No. 9569662, Recall # Z-0721-06; d) METRx II Tube, 14mm x 6cm stainless steel tubular retractor, Part No. 9569663, Recall # Z-0722-06; e) METRx II Tube, 14mm x 7cm stainless steel tubular retractor, Part No. 9569664, Recall # Z-0723-06; f) METRx II Tube, 14mm x 8cm stainless steel tubular retractor, Part No. 9569665, Recall # Z-0724-06; g) METRx II Tube, 14mm x 9cm stainless steel tubular retractor, Part No. 9569666, Recall # Z-0725-06; h) METRx II Tube, 16mm x 3cm stainless steel tubular retractor, Part No. 9569670, Recall # Z-0726-06; i) METRx II Tube, 16mm x 4cm stainless steel tubular retractor, Part No. 9569671, Recall # Z-0727-06; j) METRx II Tube, 16mm x 5cm stainless steel tubular retractor, Part No. 9569672, Recall # Z-0728-06; k) METRx II Tube, 16mm x 6cm stainless steel tubular retractor, Part No. 9569673, Recall # Z-0729-06; l) METRx II Tube, 16mm x 7cm stainless steel tubular retractor, Part No. 9569674, Recall # Z-0730-06; m) METRx II Tube, 16mm x 8cm stainless steel tubular retractor, Part No. 9569675, Recall # Z-0731-06; n) METRx II Tube, 16mm x 9cm stainless steel tubular retractor, Part No. 9569676, Recall # Z-0732-06; o) METRx II Tube, 18mm x 3cm stainless steel tubular retractor, Part No. 9569680, Recall # Z-0733-06; p) METRx II Tube, 18mm x 4cm stainless steel tubular retractor, Part No. 9569681, Recall # Z-0734-06; q) METRx II Tube, 18mm x 5cm stainless steel tubular retractor, Part No. 9569682, Recall # Z-0735-06; r) METRx II Tube, 18mm x 6cm stainless steel tubular retractor, Part No. 9569683, Recall # Z-0736-06; s) METRx II Tube, 18mm x 7cm stainless steel tubular retractor, Part No. 9569684, Recall # Z-0737-06; t) METRx II Tube, 18mm x 8cm stainless steel tubular retractor, Part No. 9569685, Recall # Z-0738-06; u) METRx II Tube, 18mm x 9cm stainless steel tubular retractor, Part No. 9569686, Recall # Z-0739-06; v) METRx II Tube, 20mm x 3cm stainless steel tubular retractor, Part No. 9569720, Recall # Z-0740-06; w) METRx II Tube, 20mm x 4cm stainless steel tubular retractor, Part No. 9569721, Recall # Z-0741-06; x) METRx II Tube, 20mm x 5cm stainless steel tubular retractor, Part No. 9569722, Recall # Z-0742-06; y) METRx II Tube, 20mm x 6cm stainless steel tubular retractor, Part No. 9569723, Recall # Z-0743-06; z) METRx II Tube, 20mm x 7cm stainless steel tubular retractor, Part No. 9569724, Recall # Z-0744-06; aa) METRx II Tube, 20mm x 8cm stainless steel tubular retractor, Part No. 9569725, Recall # Z-0745-06; bb) METRx II Tube, 20mm x 9cm stainless steel tubular retractor, Part No. 9569726, Recall # Z-0746-06; cc) METRx II Tube, 22mm x 3cm stainless steel tubular retractor, Part No. 9569730, Recall # Z-0747-06; dd) METRx II Tube, 22mm x 4cm stainless steel tubular retractor, Part No. 9569731, Recall # Z-0748-06; ee) METRx II Tube, 22mm x 5cm stainless steel tubular retractor, Part No. 9569732, Recall # Z-0749-06; ff) METRx II Tube, 22mm x 6cm stainless steel tubular retractor, Part No. 9569733, Recall # Z-0750-06; gg) METRx II Tube, 22mm x 7cm stainless steel tubular retractor, Part No. 9569734, Recall # Z-0751-06; hh) METRx II Tube, 22mm x 8cm stainless steel tubular retractor, Part No. 9569735, Recall # Z-0752-06; ii) METRx II Tube, 22mm x 9cm stainless steel tubular retractor, Part No. 9569736, Recall # Z-0753-06 REASON: Due to a manufacturing error, after autoclaving, the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off.

MANUFACTURER: Fischer Imaging Corporation, Denver, CO, by letter on March 27, 2006, firm initiated recall is ongoing.

PRODUCT: SenoScan Full Field Digital Mammography System, Product number 94001G-3, 105200G, Recall # Z-0757-06

REASON: Software upgrade to preclude lost images during mammography procedure.

MANUFACTURER: Advanced Bionics Corp., Sylmar, CA, by letters on March 8, 2006, firm initiated recall is ongoing.

PRODUCT: a) The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-01, Recall # Z-0758-06; b) The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-02H, Recall # Z-0759-06

REASON: Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.

MANUFACTURER: Medtronic Cardiac Surgery Technologies, Minneapolis, MN, by letter on September 1, 2005, firm initiated recall is ongoing.

PRODUCT: Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to create an anastomosis in a rapid, automated fashion. The device creates an interrupted anastomosis without the need for aortic clamping. A specially designed aortic cutting device (ACD) (sold separately) is utilized to create the site for the anastomosis, Recall # Z-0763-06

REASON: Customers stated that the U-Clip deployment collar was either difficult to rotate or “locks up" during usage, which prevents the deployment of the U-Clips.

MANUFACTURER: Synovis Surgical Innovations A division of Synovis Life Technologies, Inc., St. Paul, MN, by telephone and letters beginning on November 1, 2005, firm initiated recall is ongoing.

PRODUCT: Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized, Recall # Z-0764-06

REASON: The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.

CLASS III

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on February 6, 2006, firm initiated recall is ongoing.

PRODUCT: GE Healthcare Navigation Pin Transmitter Catalog Number 1004070, Medical Systems Insta Trak Pin Transmitter, Recall # Z-0709-06

REASON: Small retaining pin may detach and fall into the surgical field during stereotactic surgery.

MANUFACTURER: Medtronic Navigation, Inc., Louisville, CO, by letter on February 1, 2006, firm initiated recall is complete.

PRODUCT: AxiEM EM Knee Kit, and associated workstation, Catalog number: 9732140, Recall # Z-0718-06

REASON: Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during

MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by telephone on February 16, 2006. Manufacturer: AGFA, Corp., Goose Creek, SC, firm initiated recall is ongoing.

PRODUCT: a) Cronex™ 10T, 14 x 17, Medical Screen Film, X-ray Film, 100 Sheet Box, Product code: LF5Ha, Recall # Z-0754-06; b) Curix™ Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14 x 17, 100 Sheet Box, Product code: EKQEG, Recall # Z-0755-06; c) Radiomat™ SG, 11 x 14, Medical Screen Film, X-ray Film, 100 Sheet Box, and 14 x 17, 100 Sheet Box, Product code: EK8JR and Product Code: EK8DG, Recall # Z-0754-06;

REASON: A localized fog pattern appears on the film.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 12, 2006

CLASS II

MANUFACTURER: Stryker Medical, Kalamazoo, MI, by visit beginning on January 17, 2006, firm initiated recall is ongoing.

PRODUCT:a) Stryker Epic Critical Care Bed, Model 2030, Recall # Z-0554-06; b) Stryker Epic Zoom Critical Care Bed, Model 2040, Recall # Z-0555-06

REASON:The bed exit may not alarm as appropriate.

MANUFACTURER: Recalling Firm: Apple Medical Corporation, Marlborough, MA, by letters dated March 21, 2006.

Manufacturer: Geotec, Inc., Warwick, RI, firm initiated recall is ongoing.

PRODUCT: a) Fischer Cone Biopsy Excisor – Small Model: 900-150, Recall # Z-0614-06; b) Fischer Cone Biopsy Excisor - Medium Model: 900-151, Recall # Z-0615-06; c) Fischer Cone Biopsy Excisor – Large Model: 900-152, Recall # Z-0616-06; d) Fischer Cone Biopsy Excisor – Medium - Ext Model: 900-154, Recall # Z-0617-06; e) Fischer Cone Biopsy Excisor – Large - Shallow Model: 900-155, Recall # Z-0618-06; f) Fischer Cone Biopsy Excisor – Dual Sets Model: 900-156, Recall # Z-0619-06; g) Fischer Cone Biopsy Excisor – Model: 900-157, Recall # Z-0620-06; h) Fischer Cone Biopsy Excisor – Model: 900-158, Recall # Z-0621-06

REASON: Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to e retrieved from patient.

MANUFACTURER: Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO, by letter on November 2, and November 3, 2005.

Manufacturer: Gambro Hospal Industrie, Meyzieu Cedex (Lyon), France, firm initiated recall is ongoing.

PRODUCT: a) Gambro Prisma M100 preset, Recall # Z-0705-06; b) Gambro Prisma HF1000 preset, Recall # Z-0706-06

REASON: After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.

MANUFACTURER: Ev3, Plymouth, MN, by visit beginning February 27, 2006, firm initiated recall is ongoing.

PRODUCT: ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. The self-expanding stent is made of nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. The stent is cut from a nitinol tube into an open lattice design and is designed with tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts, Recall # Z-0707-06

REASON: Mispackaging-Protege GPS SER6-9-60-125 devices were incorrectly packaged as SER6-7-80-135. Diameter is larger than expected.

MANUFACTURER: Recalling Firm: Fujinon, Inc., Wayne, NJ, by Bulletin on March 27, 2006. Manufacturer: Fujinon Corporation, Saitama, Japan, firm initiated recall is ongoing.

PRODUCT: Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes. Catalog Numbers: EC-450HL5; EC-450LP5; EC-250HL5; EC-250LP5; EC-450HL5-UP; EC-450LP5-UP; EC-250HL5-UP; EC-250LP5-UP, Recall # Z-0708-06 REASON; Colonoscope insertion tube is not bending properly and is stiff.

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters dated March 2006, firm initiated recall is ongoing.

PRODUCT: Lifepak 12 defibrillator/monitor, Recall # Z-0710-06

REASON: Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.

MANUFACTURER: Siemens Medical Solutions USA Inc., Knoxville, TN, by letter beginning March 28, 2006, firm initiated recall is ongoing.

PRODUCT: ECAT Emerge PET Scanners (distributed by Siemens Medical Solutions USA, Inc.), ECAT ART PET Scanners (distributed by Siemens Medical Solutions USA, Inc.) and Sceptre PET Scanners (distributed by Hitachi Medical Systems of America), a) Software versions 7.2.2 rel 2, 7.2.2 rel 4A, 7.2.2 rel 5 and 7.3 Model: ART Model Number: 3600066-00; b) Model: ART Model Number: 3600078-00; c) Model: ART Model Number: 3600082-00; d) Model: ART Model Number: 3600084-00; e) Model: ART 2000 Model Number: 3600090-00; f) Model: EMERGE, EMERGE (Toshiba), EMERGE (Sceptre - Hitachi), EMERGE m (Sceptre - Hitachi), PICO EMERGE (Sceptre-Hitachi), PICO EMERGEm (Sceptre – Hitachi) Model Number: 3600099-00; g) Model Number: PICO EMERGE (Sceptre-Hitachi) Model Number: P008060, Recall # Z-0712-06

REASON: There is a potential for inaccurate, elevated SUVs (standardized uptake values). On follow-up scans, the elevated SUV could be misinterpreted, and inappropriately impact a patient's treatment plan.

MANUFACTURER: Sonosite, Inc., Bothell, WA, by a User Guide Addendum on October 26, 2005, firm initiated recall is complete.

PRODUCT: SonoCalc IMT 3.0, windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery, Recall # Z-0713-06

REASON: When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular events. Under estimates percentage of stenosis, false negative result.

CLASS III

MANUFACTURER: Recalling Firm: Smiths Medical ASD, Inc., Keene, NH, by letter dated March 7, 2006 Manufacturer: Smiths Medical, Hythe, UK, firm initiated recall is ongoing.

PRODUCT: Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080, Recall # Z-0714-06

REASON: Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 5, 2006

CLASS II MANUFACTURER:

Recalling Firm: Toshiba American Med Systems, Inc., Tustin, CA, by letter beginning February 23, 2006.

Manufacturer: Cmt Medical Technologies Ltd, Haifa, Israel, firm initiated recall is ongoing.

PRODUCT: Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device, Recall # Z-0533-06

REASON: When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiring images or will continue to acquire blank images. The remote console will lock-up upon release of the hand switch. The operator must reboot the system. This will result in the loss of the images acquired during the contrast portion of the study.

MANUFACTURER:

Recalling Firm: Baxter Healthcare, Corporation, Round Lake, IL, by letters dated August 3, 2005 and December 15, 2005.

Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR, firm initiated recall is ongoing.

PRODUCT: a) Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N8371; An Rx sterile, nonpyrogenic fluid pathway, 6.0", mL Vol., with 2 Luer Activated Valves and a male Luer Lock adapter; Recall # Z-0625-06; b) Baxter Non-DEHP Y-Type Catheter Extension Set, product code 2N1191; An Rx sterile, nonpyrogenic fluid pathway, 4.8', 0.6 mL Vol., with male Luer Lock adapter; Recall # Z-0626-06; c) Baxter Minivolume Extension Set, product code 2C5681; An Rx sterile, nonpyrogenic fluid pathway, 6.4", 0.4 mL Vol., with male Luer Slip T-Connector, Recall # Z-0627-06; d) Baxter Non-DEHP I.V. Catheter Extension Set, product code 2N1194, An Rx sterile, nonpyrogenic fluid pathway, 7.0", 0.3 mL Vol., with male Luer Lock adapter, Recall # Z-0628-06; e) Baxter Interlink System Non-DEHP Standard Bore 3-Lead Catheter Extension Set, product code 2N3335; An Rx sterile, nonpyrogenic fluid pathway with 2 Interlink injection sites and a male Luer Lock adapter; Recall # Z-0629-06; f) Baxter Interlink System T-Connector Extension Set, product code 2N3343; An Rx sterile, nonpyrogenic fluid pathway, 7.0", 1.0 mL Vol., with 1 Interlink T-connector injection sites and male Luer Lock adapter with retractable collar and 1 Interlink Y-injection site. Recall # Z-0630-06; g) Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3345; An Rx sterile, nonpyrogenic fluid pathway, 36", 0.38mL Vol, with male Luer Lock adapter, Recall # Z-0631-06; h) Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348; An Rx sterile, nonpyrogenic fluid pathway, 60", 0.5mL Vol, with male Luer Lock adapter, Recall # Z-0632-06; i) Baxter Non-DEHP High Flow Rate Extension Set, product code 2N3349; An Rx sterile, nonpyrogenic fluid pathway, 60', 2.14mL Vol, with male Luer Lock adapter; Recall # Z-0633-06; j) Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, product code 2N3384; An Rx sterile, nonpyrogenic fluid pathway, 9.0", 0.5 mL Vol., with injection site and male Luer Lock adapter with Retractable Collar. Recall # Z-0634-06; k) Baxter Mini-Infuser Microbore Extension Set, product code 2C9203; An Rx sterile, nonpyrogenic fluid pathway, 61", 0.9 mL Vol., with male Luer Lock adapter, Recall # Z-0635-06; l) Baxter Anesthesia Set, product code 2C9216; An Rx sterile, nonpyrogenic fluid pathway, 72", 1.7 mL Vol., with Luer Lock adapters, Recall # Z-0636-06; m) Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0", 0.86 mL Vol., with 2 injection sites and male Luer Lock adapter, Recall # Z-0637-06; n) Baxter Interlink System Minivolume Extension Set, product code 1C8378; An Rx sterile, nonpyrogenic fluid pathway, 9.0", 0.6 mL Vol., with injection site and male Luer Lock adapter, Recall # Z-0638-06; o) Baxter Minivolume Extension Set, product code 1C8400; An Rx sterile, nonpyrogenic fluid pathway, 13.0", 0.4 mL Vol., with male Luer Lock adapter, Recall # Z-0639-06; p) Baxter Interlink System Minivolume Extension Set, product code 1C8412; An Rx sterile, nonpyrogenic fluid pathway, 16.0", 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer Lock adapter, Recall # Z-0640-06; q) Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0", 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstream High Pressure Extended Life Filter and male Luer Lock adapter, Recall # Z-0641-06; r) Baxter Interlink System Minivolume Extension Set, product code 1C8483; An Rx sterile, nonpyrogenic fluid pathway, 18', 1.3 mL Vol. with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer Lock adapter, Recall # Z-0642-06; s) Baxter Interlink System Minivolume Extension Set, product code 1C8590; An Rx sterile, nonpyrogenic fluid pathway, 22", 0.9 mL Vol, with injection site and Stationary Swivel Lock T-Connector, Recall # Z-0643-06; t) Baxter Interlink System Minivolume Extension Set, product code 1C8643; An Rx sterile, nonpyrogenic fluid pathway, 7", 0.3 mL Vol, with Male Luer Slip T-Connector, Recall # Z-0644-06; u) Baxter Non-DEHP Minivolume Extension Set, product code 1C8690; An Rx sterile, nonpyrogenic fluid pathway, 8", 0.22 mL Vol, with male Luer Lock adapter, Recall # Z-0645-06; v) Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid pathway; extension set: 19", 3.2 mL Vol., with injection site and male Luer Lock adapter, manifold extension set: 46", 6.2 mL Vol, male luer adapter, and minivolume extension set: 10", 0.7 mL Vol, injection site and stationary swivel lock T-connector, Recall # Z-0646-06; w) Baxter Interlink System 3-Lead Extension Set, product code 1C8442; An Rx sterile, nonpyrogenic fluid pathway, 6", 1.6 mL Vol., with 2 Interlink Injection Sites and a Male Luer Lock adapter;, Recall # Z-0647-06; x) Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0", 0.8 mL Vol., with 2 injection sites and male Luer Lock adapter, Recall # Z-0648-06; y) Baxter Y-Type Minivolume Extension Set, product code 1C8689; An Rx sterile, nonpyrogenic fluid pathway, 6.0", 0.33 mL Vol., with male Luer Lock adapter, Recall # Z-0649-06; z) Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8705; An Rx sterile, nonpyrogenic fluid pathway, 7.0", 0.33 mL Vol., with Luer Activated Valve for IV Access and male Luer Lock adapter, Recall # Z-0650-06; aa) Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8739; An Rx sterile, nonpyrogenic fluid pathway, 8.0", 0.6 mL Vol., with Luer Activated Valve for IV Access and male Luer Lock adapter, Recall # Z-0651-06; bb) Baxter Interlink System Minivolume Extension Set, product code 1C8740; An Rx sterile, nonpyrogenic fluid pathway, 16.0", 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer Lock adapter, Recall # Z-0652-06; cc) Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrogenic fluid pathway; solution set: 74", 60 drops/mL, with injection site and male Luer Lock adapter, manifold extension set: 29", 4 mL Vol, male luer adapter, and minivolume extension set: 7", 0.4 mL Vol with retractable T-connector. Recall # Z-0653-06; dd) Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set and Minivolume Extension Set, product code 3C0108; An Rx sterile, nonpyrogenic fluid pathway; solution set: 58", 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection sites and male Luer Lock adapter, stopcock extension set: 43", 6.5 mL Vol with 2 injection sites and male luer adapter, and minivolume extension set: 6", 0.4 mL Vol with male luer slip T-connector, Recall # Z-0654-06; ee) Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock Extension Set and Minivolume Extension Set, product code 3C0128; An Rx sterile, nonpyrogenic fluid pathway; solution set: 105", 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 3 injection sites and male Luer Lock adapter, stopcock extension set: 34", 5.2 mL Vol with injection site, minivolume tubing and male luer adapter, and minivolume extension set: 3", 0.1 mL Vol with male luer lock adapter, Recall # Z-0655-06; ff) Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set and Extension Set, product code 3C0172; An Rx sterile, nonpyrogenic fluid pathway; solution set: 84", 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 3 injection sites and male Luer Lock adapter, stopcock extension set: 21", 3.2 mL Vol with 2 injection sites and male luer adapter, and minivolume extension set: 6", 0.5 mL Vol with microvolume tubing and retractable T-connector, Recall # Z-0656-06; gg) Baxter Minivolume Extension Set, product code JC9944; An Rx sterile, nonpyrogenic fluid pathway, 8", 0.4 mL Vol., with Luer Activated Valve, Made in Canada, Recall # Z-0657-06

REASON: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

MANUFACTURER: Masimo Corporation, Irvine, CA, by letter on February 2, 2006, firm initiated recall is ongoing.

PRODUCT: Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse Co¬Oximeter, Recall # Z-0661-06

REASON: Internal testing revealed that some of the sensors might not meet the accuracy specifications of : 2% for SpO2 and of: 3% for SpCO, due to the tolerance of one of the emitter LED's used in the calculation ofSpO2 and SpCO. The SpO2 reading may have a negative bias of up to 1 % and the SpCO reading may have a negative bias of up to 4%.

MANUFACTURER: Stryker Instruments Div. Of Stryker Corporation, Portage, MI, by letter dated February 7, 2006, firm initiated recall is ongoing.

PRODUCT: a) Stryker PainPump 1 Base Kit; Product number 500-100-000, Recall # Z-0662-06; b) Stryker PainPump 1 5-Day Infusion Kit; Product number 500-110-000, Recall # Z-0663-06; c) Stryker PainPump 1 2-Day Infusion Kit; Product number 500-120-000, Recall # Z-0664-06; d) Stryker PainPump 1 1-Day Infusion Kit; Product number 500-140-000, Recall # Z-0665-06; e) Stryker PainPump 1 2-Site Y -Connector; Product number 500-200-000, Recall # Z-0666-06; f) Stryker PainPump 1 2-Site Y -Connector; Product number 500-250-000, Recall # Z-0667-06; g) Stryker PainPump 1.5 Base Infusion Kit; Product number 501-100-000, Recall # Z-0668-06; h) Stryker PainPump 1.5 5-Day Infusion Kit; Product number 501-120-000, Recall # Z-0669-06; i) Stryker PainPump 1.5 2-Day Infusion Kit; Product number 501-140-000, Recall # Z-0670-06

REASON: The catheter tubing included in the kit may break during removal.

MANUFACTURER: Cook Urological, Inc, Spencer, IN, by letter dated March 1, 2006, firm initiated recall is ongoing.

PRODUCT: Cook Harrison fetal bladder stent set, sterile; RF J-HFBS-503540, Recall # Z-0674-06

REASON: Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.

MANUFACTURER: American Medical Systems, Minnetonka, MN, by letter dated January 25, 2006, firm initiated recall is ongoing.

PRODUCT: AMS Her Option Cryoablation Therapy Disposable Probe her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile, the Her Option Cryoablation Therapy System consists of a Console, a Cryoprobe and a Disposable Probe, Recall # Z-0675-06

REASON: Overheating of the Cryoablation Therapy Disposable Probe (CU-1), could cause a burn injury to a patient or user in certain circumstances.

MANUFACTURER: Recalling Firm: Alfa Wassermann, Inc., West Caldwell, NJ, by letters on January 14, 2006- January 17, 2006-January 19, January 27, 30, 31 and February 1, 2006, firm initiated recall is ongoing.

PRODUCT: General Reference Serum (magnesium calibrator). Calibrator, Multianalyte Mixture. Level 1 and Level 2 Chemistry Control, Catalog number: S1-32, Recall # Z-0676-06

REASON: Inaccurate test results. The magnesium values for the A31/A41 General Serum calibrator gave control results that were biased approx. 20% high.

MANUFACTURER: Recalling Firm: St. Jude Medical/Daig Division, Minnetonka, MN, by e-mail and letters on August 22, 2005. Manufacturer: St. Jude Medical, Puerto Rico B.V., Caguas, PR, firm initiated recall is ongoing.

PRODUCT: Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only, Recall # Z-0677-06

REASON: Mispackaging -- Some Angio-Seal 6F STS Vascular Closure Devices have been incorrectly packaged with a 0.035’ guidewire instead of a 0.032’ guidewire.

MANUFACTURER: Shelhigh, Inc., Union, NJ, by telephone on January 18, 2006, firm initiated recall is complete.

PRODUCT: Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React®, Pulmonic Valve Conduit, NR4000-PA-C, Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React®' treatment*, INSTRUCTIONS FOR USE, Recall # Z-0678-6

REASON: Unapproved Device-Distribution of an unapproved device into interstate commerce.

MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Division, Mc Gaw Park, IL, by letters dated December 21, 2005. Manufacturer: Mesys Gmbh. Hannover. Germany, firm initiated recall is ongoing.

PRODUCT: a) Baxter BM25 System ultrafiltration hemodialysis machine; The BM25 System is composed of a BM11A Blood Monitor Pump (5M3051/5M3051R) and a BM14 Ultrafiltration Monitoring Module (5M3052/5M3052R), with a cart with scales (5M3053); product code GEF042-10 in China, Recall # Z-0679-06; b) Baxter BM11A Blood Monitor Pump hemodialysis machine; product code 5M3051, 5M3051R, Recall # Z-0680-06; c) Baxter BM11 Blood Monitor Pump hemodialysis machine; product code 5M3005, 5M3005R, Recall # Z-0681-06

REASON: Advisory to alert users to assure that the hemofilter of the blood line is in the horizontal position to avoid kinking of the bloodline tubing to avoid hemolysis, and to show the compatible blood tubing sets to be used with the BM 11/BM 11A Blood Monitor Pump and BM25 System ultrafiltration hemodialysis system.

MANUFACTURER: Recalling Firm: Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, by E-mails on January 20, 2006.

Manufacturer: Bayer Healthcare, LLC (Diagnostics Division), Norwood, MA, firm initiated recall is ongoing.

PRODUCT: a) Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system, Recall # Z-0682-06; b) Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system, Recall # Z-0683-06; c) Brand Name: RapidLab 1200 System, Model 1260, Part Number 05062460; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system, Recall # Z-0684-06; d) Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte and blood pH test system, Recall # Z-0685-06

REASON: When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.

MANUFACTURER: Kerr Corporation, Orange, CA, by letters on March 3 and 6, 2006, firm initiated recall is ongoing.

PRODUCT: a) Tooth bonding resin. Optibond Solo Plus, Part number 31513, Recall # Z-0686-06; b) Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part number 31514, Recall # Z-0687-06; c) Tooth bonding resin. Optibond Solo Plus Dual Cure Kit, Part number 31736, Recall # Z-0688-06; d) Tooth bonding resin. Nexus 2 Kit, Part number 31954, Recall # Z-0689-06; e) Tooth bonding resin. Nexus 2 Starter Kit, Part number 31955, Recall # Z-0690-06; f) Tooth bonding resin. Premise Master Syringe Kit, Part number 32611, Recall # Z-0691-06; g) Tooth bonding resin. Premise Master Unidose Kit, Part number 32612, Recall # Z-0692-06; h) Tooth bonding resin. Premise Starter Unidose Kit, Part number 32684, Recall # Z-0693-06

REASON: The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.

MANUFACTURER: Recalling Firm: Fisher and Paykel Healthcare, Inc., Laguna Hills, CA, by letter on December 20, 2005. Manufacturer: Fisher and Paykel Ltd., Auckland, New Zealand, firm initiated recall is ongoing.

PRODUCT: a) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated, Catalogue Number RT110, Recall # Z-0694-06; b) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated, Catalogue Number RT111, Recall # Z-0695-06; c) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated, Catalogue Number RT210, Recall # Z-0696-06; d) Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated, Catalogue Number RT211, Recall # Z-0697-06

REASON: Risk of fire, The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire.

CLASS III

MANUFACTURER: Regeneration Technologies, Inc., Alachua, FL, by letter on October 14, 2005, firm initiated recall is ongoing.

PRODUCT: a) Osteofil + RT Allograft Paste 10cc. SINGLE PATIENT USE ONLY, Recall # Z-0698-06; b) Osteofil Allograft, 5cc, SINGLE PATIENT USE ONLY, Recall # Z-0699-06;. c) Osteofil Allograft Paste (Bio) of varying sizes, SINGLE PATIENT USE ONLY, Recall # Z-0700-06; d) Osteofil IC Syringeable of varying sizes. SINGLE PATIENT USE ONLY, Recall # Z-0701-06; e) Osteofil ICM Moldable Strip of varying sizes. SINGLE PATIENT USE ONLY, Recall # Z-0702-06; f) Osteofil RT, ICM Allograft Paste in varying sizes. SINGLE PATIENT USE ONLY, Recall # Z-0703-06

REASON: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 29, 2006

CLASS II

MANUFACTURER: Endologix, Inc., Irvine, CA, by telephone and letters on December 14, and 19-22, 2005, firm initiated recall is ongoing.

PRODUCT: a) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL, Recall # Z-0589-06; b) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL, Recall # Z-0590-06; c) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System)Model No. 25-16-135BL, Recall # Z-0591-06; d) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL, Recall # Z-0592-06; e) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL, Recall # Z-0593-06; f) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL, Recall # Z-0594-06; g) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL, Recall # Z-0595-06; h) Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System)
Model No. 28-16-155BL, Recall # Z-0596-06;

REASON: The tip may separate from the catheter sheath inner core during insertion of the graft. The delivery catheter is being recalled. The implanted devices are not affected.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated February 7, 2006. Manufacturer: Baxter Healthcare Corp., Singapore, firm initiated recall is ongoing.

PRODUCT: Baxter Auto Syringe AS50 Infusion Pump, product code 1 M8550, Recall # Z-0612-06

REASON: A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.

MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by telephone on December 8, 2005, firm initiated recall is complete.

PRODUCT: a) Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.Model Number CC1301 (Reorder No. 21-0334-01)Primary Checkvalve set for Secondary (piggyback) Administration. Sterile, non-pyrogenic. Length 115 inch/292 cm, 27 ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites, Recall # Z-0658-06;b) Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 1 needless injection site, Recall # Z-0659-06;c) Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.Model Number 8C290 (Reorder No.21-0304-01) Speciality Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 0 Injection sites, PVC cassette, non-PVC lined tubing, non-PVC drip chamber, Recall # Z-0660-06

REASON: Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.

CLASS III

MANUFACTURER: Recalling Firm: Bard Access Systems, Inc, Salt Lake City, UT, by letter on December 20, 2005. Manufacturer: Bard Reynosa S.A. De C.V., Reynosa, Mexico, firm initiated recall is ongoing.

PRODUCT: a) Groshong nXt ClearVue 4 Fr Single-Lumen PICC, Product code 7617405, Recall # Z-0541-06; b) Groshong nXt ClearVue 4 Fr. Single-Lumen PICC, Product Code 7617408, Recall # Z-0542-06; c) Groshong nXt 5 Fr. Dual-Lumen Reverse Taper PICC, Product Code 7827508, Recall # Z-0543-06;d) Groshong nXt 5 Fr. Dual-Lumen Reverse Taper PICC, Product Code 7927508, Recall # Z-0544-06

REASON: Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 22, 2006

CLASS II

MANUFACTURER: Recalling Firm: Abbott Diabetes Care, Inc., Alameda, CA, by visit on February 17, 2006 and by letters on February 22, 2006, firm initiated recall is ongoing.

PRODUCT: a) FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips; Part Number: 70672-01, Recall # Z-0604-06; b) FreeStyle Connect Blood Glucose Test Strips; Part Number: CAT70676-01, Recall # Z-0605-06

REASON: The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.

MANUFACTURER: Biogenex Laboratories, San Ramon, CA, by letters on February 9, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Test kit used in the assessment of breast cancer patients for whom Herceptin therapy
is being considered. BioGenex brand InSiteHER-2/neu IHC Kit, Manual; Model Numbers: RD134-60K, Recall # Z-0606-06; b) Test kit used in the assessment of breast cancer patients for whom Herceptin therapy
is being considered. BioGenex brand InSite HER-2/neu IHC Kit, Automated; Model Numbers: RD134-YAX, Recall # Z-0607-06; c) Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Manual; Model number: AM134-5MP, Recall # Z-0608-06; d) Test kit used in the assessment of breast cancer patients for whom Herceptin therapy is being considered. BioGenex brand InSite HER-2/neu Monoclonal Antibody, Automated; Model number: AM134-10MP, Recall # Z-0609-06

REASON: Products produce granular staining in immunostained tissue sections, which may lead to misdiagnosis due to false positive result.

MANUFACTURER: BD Opthalmic Systems, Waltham, MA, by telephone on February 28, 2006, firm initiated recall is ongoing.

PRODUCT: BD Xstar Bevel Up Slit Knife 2.8 mm, Sterile Catalog number: 373728, Recall # Z-0613-06

REASON: Product labeled as a 2.8 mm may contain a 3.2 mm Xstar.

MANUFACTURER: Fujifilm Medical System USA, Inc., Stamford, CT, by letter dated February 3, 2006, firm initiated recall is ongoing.

PRODUCT: Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS, Recall # Z-0622-06

REASON: Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.

MANUFACTURER: Recalling Firm: Cardiac Science, Inc., Bothell, WA, by telephone and letter dated February 2, 2006. Manufacturer: Quinton Cardiology, Inc., Deerfield, WI, firm initiated recall is ongoing.

PRODUCT: Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic), Recall # Z-0623-06

REASON: Some Powerheart AEDs Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.

MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letter, dated March 23, 2005, firm initiated recall is ongoing.

PRODUCT: In vitro Test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Reagent Pack 100 test TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators are composed of six vials of calibrators A, B, C, D, E, and F containing cyclosporine prepared in human blood component (non-reactive for HBxAg, anti-HCv, anti-HIV-1/HIV-20. TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Controls are composed of three vials L, M and H containing cyclosporine in human blood componenet (nonreactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2). Recall # Z-0624-06

REASON: Important Product Information Letter containing technical information regarding the TDx/TDxFLx Cyclosporine Monoclonal Whole Blood Calibrators and Controls, implementing new internal reference standards. Patient results reported using calibrators made from new primary material may be falsely decreased by 5-8% compared to results using calibrators made from the previous primary material.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 15, 2006

CLASS II

MANUFACTURER: I-Flow Corporation, Lake Forest , CA , by letter dated January 17, 2006 , firm initiated recall is ongoing.

PRODUCT: a) Easypump ST 100-1 infusion pump, Recall # Z-0584-06; b) Easypump L T 60-24 infusion pump, Recall # Z-0585-06

REASON: The sterile pack may contain the wrong infusion pump inside.

MANUFACTURER: Zimmer Inc., Warsaw , IN , by email on February 22, 2006, firm initiated recall is ongoing.

PRODUCT: Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, Zimmer brand, sterile, Size 3, Right; Ref 7356-02-103, Recall # Z-0597-06

REASON: Misbranded, the package actually contains an APR hip system, HA porous stem, 12 mm, left.

MANUFACTURER: Recalling Firm: Orthohelix Surgical Designs, Inc., Akron , OH , by telephone and visits between November 1, and November 7, 2005 . Manufacturer: Troy Innovative Instruments, Inc., Garrettsville , OH , firm initiated recall is ongoing.

PRODUCT: MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System, Recall # Z-0598-06

REASON: Screwdriver pilot taper tip can break during surgery.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake , IL , by letters dated 2/8/06 . Manufacturer: Baxter Healthcare Corp., Singapore , firm initiated recall is ongoing.

PRODUCT: Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug library option) and product codes 1M8560 and 1M8560R (pumps without drug library option), Recall # Z-0599-06

REASON: The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.

MANUFACTURER: Cook, Inc., Bloomington , IN , by telephone and fax on January 26, 2006 , firm initiated recall is ongoing.

PRODUCT: Cook Zilver 635 Biliary Stent – Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-8.0-40, Recall # Z0600-06

REASON: The side of the boxes give incorrect sizes for these stents. The label front is correct.

MANUFACTURER: Hospira, Inc., Morgan Hill , CA , by letters on November 2, 2005 , firm initiated recall is ongoing.

PRODUCT: Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09, Recall # Z-0601-06

REASON: Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.

CLASS III

MANUFACTURER: Recalling Firm: Straumann Manufacturing Inc., Andover , MA , by letter dated January 30, 2006 . Manufacturer: Institut Straumann, AG, Basel , Switzerland , firm initiated recall is ongoing.

PRODUCT: a) Thermoplastic templates, single tooth, Catalog Number 040.526, Recall # Z-0602-06; b) Thermoplastic templates, free-end situation, Catalog Number 040.527, Recall # Z-0603-06

REASON: Pilot drills may not fully extend through drill guide in template products.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 8, 2006:

CLASS II

MANUFACTURER: Toshiba America Medical Systems, Inc., Tustin, CA, by software installation beginning on February 22, 2006. Firm initiated recall is on going.

PRODUCT: Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film device for diagnostic fluoroscopic imaging, Recall # Z-0533-06

REASON: Systems are defective under 21 CFR 1003.2 in that they may deliver radiation unintended to their use.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters beginning on January 5, 2006 and January 9, 2006. Manufacturer: Nova Biomedical Corp., Waltham, MA, firm initiated recall is ongoing.

PRODUCT: a) BD Logic – Blood Glucose Monitor, Catalog numbers: 322051(48), 322029, 322068, 322069, Recall # Z-0560-06;b) BD Latitude (DMS) – Blood Glucose Monitor, Catalog numbers: 322050, 322000, 322015, 322067, Recall # Z-0561-06;c) Paradigm Link – Blood Glucose Monitor, Catalog numbers: 322200; 322201; 322202; 322203; 322204; 322205; 322206; 322207, Recall # Z-0562-06;

REASON: BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.

MANUFACTURER: Inovise Medical, Inc., Portland, OR, by telephone on January 12, 2006, and by visit on January 16-17-2006. Firm initiated recall is ongoing.

PRODUCT: AUDICOR 200 D Inovise Part Number 30047 (console part number 20158), Recall # Z-0565-06

REASON: Use of the AUDICOR 200 D in-line with a defibrillator/monitor resulted in interruption of pacing therapy to a patient when the AUDICOR 200 D stopped working due to low battery power.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letters dated February 10, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030381001,12030365001, 04388208001, 04388186001 and 03000141001. (Sold in the United States), Recall # Z-0566-06;b) Accu-Chek Advantage blood glucose test strips; Reference numbers 03144917001, 03144704001, 03145263001, (sold within the United States) and 12030551001, 12030578001 and 12030586001 (sold outside of the United States), Recall # Z-0567-06;c) Accu-Chek Advantage II blood glucose test strips; Reference numbers 12030659001, 12030667001, 03137872001, 03137899001, 03000281001, 12030535001, 12030543001, 03033449001, 03033465001 and 12030543047 (All sold outside of the United States), Recall # Z-0568-06; d) Accu-Chek Advantage Plus blood glucose test strips; Reference number 04735102001 (All sold outside of the United States), Recall # Z-0569-06;e) Accu-Chek Advantage Pro blood glucose test strips; Reference number 04534972001 (All sold outside of the United States), Recall # Z-0570-06;d glucose test strips; Reference numbers 03261956170, 03261964170, 03146154192, 03146146192, 03374700023, 03374718023, 11895133192, 11895141192, 03522091016, 03051161003, 03051170003, 03322033122, 03322041122 and 03587304122 (All sold outside of the United States), Recall # Z-0571-06;g) Accu-Chek Sensor Comfort Pro blood glucose test strips; Reference numbers 0375877001, 03360652080, 03051188003, 03620115003 and 04535235003 (All sold outside of the United States), Recall # Z-0572-06

REASON: There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone and letter on or about February 10, 2006. Manufacturer: Microgenics Corp., Fremont, CA, Firm initiated recall is ongoing.

PRODUCT: Roche brand CEDIA Tobramycin II Reagent Catalog # 1815385, Material # 11815385216, Recall # Z-0574-06

REASON: Product may have tobramycin over-recovery at the trough level.

MANUFACTURER: Gish Biomedical Inc., Rancho Santa Margarita, CA, by letter on November 14, 2005. Firm initiated recall is ongoing.

PRODUCT: The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming volume, and reduces shunting. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross filter and pressure relief device designed to open in the event of excessive fluid pressure during use. Solutions are delivered to the patient through a roller pump through the table line extension and appropriate cannula, Recall # Z-0575-06

REASON: The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.

MANUFACTURER: Recalling Firm: Praxair Distribution, Inc., Middleburg Heights, OH, by letter, dated December 21, 2005. Manufacturer: Western -- Scott Fetzer Company, Westlake, OH, firm initiated recall is ongoing.

PRODUCT: a) Praxair Grab’n Go Vantage unit, model PRX-9495, Recall # Z-0579-06;b) Praxair Grab’n Go Vantage unit, model PRX-9496, Recall # Z-580-06

REASON: The units may experience a delay in oxygen flow upon initial actuation.

MANUFACTURER: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on February 6, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Allura Xper FD10/10 x-ray system, Recall # Z-0581-06;b) Allura Xper FD10 x-ray system,Recall # Z-0582-06

REASON: Potential lock-up of system requiring reboot of system.

MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter the week of February 6, 2006.

Manufacturer: Beckman Coulter, Inc., Chaska, MN, firm initiated recall is ongoing.

PRODUCT: UniCel Dxl 800 Access Immunoassay System, Recall # Z-0583-06

REASON: The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)

MANUFACTURER: Recalling Firm: B. Braun Medical Inc, Irvine, CA, by letter between December 1, 2005 and January 11, 2006. Manufacturer: Stedim, S.A., Aubagne Cedex, France, firm initiated recall is ongoing.

PRODUCT: B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Recall # Z-0586-06

REASON: A small percentage of the lots leak from the set port when the set port is opened. The leak was identified by Stedim to be due to the incorrect placement of a septum in the set port. The set closure is intact and the leak remains internal until the set port is opened.

CLASS III

MANUFACTURER: Cygnus LLC, Paterson, NJ, by letter on February 14, 2005. Firm initiated recall is complete.

PRODUCT: Centrifuge Model CF-6 with lid lock. (Block Model number OCT-VI), Recall # Z-0563-06

REASON: The units were exhibiting tolerance stacking in the electronic circuit timer that controls the electric motor that spins the centrifuge and applies the centrifuge brake.

MANUFACTURER: Cygnus LLC, Paterson, NJ, by letter on September 8, 2005. Firm initiated recall is ongoing.

PRODUCT: Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch’s customers MFT and Cascade, Recall # Z-0564-06

REASON: When device was packaged, too much expanding foam was added causing the lid to deform and causing the lid locking mechanism to be out of alignment.

MANUFACTURER: Nova Biomedical Corporation, Waltham, MA, by letter on January 27, 2006, firm initiated recall is ongoing.

PRODUCT: a) Star Profile Critical Care (CCX) Analyzer Catalog Number: 35942, Recall # Z-0576-06;b) Star Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413, Recall # Z-0577-06;c) CCX Operating Software, Version 4.08, Recall # Z-0578-06

REASON: Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs.

MANUFACTURER: Inovel LLC, Culver City, CA, by letter on February 22, 2006, firm initiated recall is ongoing.

PRODUCT: Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95, Model Numbers: 3002N95-M, Recall # Z-0587-06

REASON: Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 1, 2006:

CLASS I

MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul, MN, by letter dated July 18, 2005 and January 21, 2006.

Manufacturer: Guidant-Ireland, Clomel, Ireland, firm initiated recall is ongoing.

PRODUCT: a) DISCOVERY (model nos. 1174, 1175, 1273, 1274 and 1275) pacemaker, Recall # Z-1032-05; b) MERIDIAN (model nos. 476, 976, 1176 and 1276) pacemaker, Recall # Z-1033-05; c) PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 1170, 1171, 1172, 1270 and 1272) pacemaker, Recall # Z-1034-05; d) PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker, Recall # Z-1035-05; e) DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and 1286) pacemaker, Recall # Z-1036-05; f) VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker, Recall # Z-1037-05; g) INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker, Recall # Z-1038-05; h) CONTAK TR (Model no. 1241) pacemaker, Recall # Z-1039-05

REASON: A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life.

MANUFACTURER: Recalling Firm: Davol, Inc., Subdivision of C. R. Bard, Inc., Cranston, RI, by letters on December 22, 2005, December 27, 2005 and January 5, 2006. Manufacturer: Bard, Las Piedras, PR, firm initiated recall is ongoing.

PRODUCT: a) Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7" x 10.7" Code: 0010206, Recall # Z-0524-06; b) Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8" x 13.7" (25.4cm x 33cm) Code: 0010207, Recall # Z-0525-06; c) Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7" x 9.7" (19.6cm x 24.6cm) Code: 0010208, Recall # Z-0526-06

REASON: Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula.

CLASS II

MANUFACTURER: Recalling Firm: Abbott Laboratories, Santa Clara, Ca, by letter, on December 16, 2005. Manufacturer: BD Biosciences, San Jose, CA, firm initiated recall is ongoing.

PRODUCT: CELL-DYN Sapphire Hematology Analyzer Reagents CD 3/4/8 Assay, Recall # Z-0527-06

REASON: T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.

MANUFACTURER: Recalling Firm: Toshiba American Med Sys Inc, Tustin, CA, by letter on November 15, 2005.

Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan, firm initiated recall is ongoing.

PRODUCT: Toshiba Digital Radiography System Model DFP8000D, Recall # Z-0532-06

REASON: In certain conditions the FOV of the lateral plane does not coincide with the X-ray exposed area, and consequently a part of the X-ray field may not be displayed in the magnification mode.

MANUFACTURER: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter dated December 22, 2005. Firm initiated recall is ongoing.

PRODUCT: Holt Probe Round Straight, Recall # Z-0540-06

REASON: Depth indicators are incorrectly labeled (etched) on a measurement instrument.

MANUFACTURER: Recalling Firm: Lumenis Inc., Santa Clara, CA, by letters on July 26, 2004 and February 1, 2006. Manufacturer: Lumenis, Inc., Salt Lake City, UT, firm initiated recall is ongoing

PRODUCT: Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems, Recall # Z-0545-06

REASON: The BP/Notch filter may be out of specification and may cause injury to the patients’ eyes due to high power (energy) delivered by the Laser System during medical procedures.

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on February 1, 2006, firm initiated recall is ongoing.

PRODUCT: Lifepak 500 automated external defibrillator (AED), Code Information Affected part numbers: 3011790-000012, 3011790-000113, 3011790-001129, 3011790-001131, 3011790-01132, 3011790-001133, 3011790-001153, 3011790-001168, 3011790-001171, 3011790-001182, 3011790-001186, 3011790-001191, 3011790-001194, 3011790-001203, 3011790-001207, 3011790-001208, 3011790-001210, 3011790-001213, 3011790-001215, 3011790-001240, 3011790-001241, 3011790-001265, 3011790-001285, 3011790-001307, 3011790-001310, 3011790-001316, 3011790-001317, 3011790-001319, 3011790-001322, 3011790-001324, 3011790-001326, 3011790-001329, 3011790-001334, 3011790-001338, 3011790-001341, 3011790-001342, 3011790-001343, 3011790-001344, 3011790-001358, 3011790-001359, 3011790-001361, 3011790-001362, 3011790-001366, 3011790-001374, 3011790-001379, 3011790-001397, 3011790-001412, 3011790-001415, 3011790-001416, 3011790-001422, 3011790-001438, 3011790-001452, 3011790-001453, 3011790-001456, 3011790-001470, 3011790-001479, 3011790-001480, Recall # Z-0546-06

REASON: Component leads may have intermittent connection to the printed circuit board assembly pads -- which could render the device inoperative.

MANUFACTURER: Medtronic Emergency Response Systems, Inc. Redmond, WA, by letter on January 31, 2006. Firm initiated recall is ongoing.

PRODUCT: a) LIFEPAK CR Plus defibrillator, Part number 3200731-All, Recall # Z-0547-06; b) LIFEPAK EXPRESS defibrillator, Part number 3202177-00 through --002, Recall # Z-0548-06

REASON: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.

MANUFACTURER: Recalling Firm: Lumenis, Inc., Santa Clara, CA, by letters on February 9, 2006. Manufacturer: RH USA Inc., Livermore, CA, firm initiated recall is ongoing.

PRODUCT: Lumenis brand LightSheer Pulsed Diode Array Laser System, Recall # Z-0556-06

REASON: During hair removal treatment, patients’ skin can experience burns due to debris accumulating on the sapphire crystal tip.

MANUFACTURER: Diasorin Inc., Stillwater, MN, by telephone and letter dated August 8, 2005. Firm initiated recall is ongoing. PRODUCT: The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1), Recall # Z-0557-06 REASON: Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay and/or ETI-VZV lgG.

MANUFACTURER: Recalling Firm: Acclarent, Inc., Menlo Park, CA, by letters on January 20, 2006. Manufacturer: Argon Medical, Athens, TX, firm initiated recall is ongoing.

PRODUCT: Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10" extension tube, 1-20cc syringe, 3-way stop-cock, Catalog # BID30, Recall # Z-0559-06

REASON: Lack of assurance of sterility-device for which sterility may be compromised as evidenced by a loss of package integrity.

CLASS III

MANUFACTURER: Recalling Firm: Tosoh Bioscience Inc., Grove City, OH, by letter dated January 26, 2006.

Manufacturer: Tosoh AIA, Inc., Toyama, Japan, firm initiated recall is ongoing.

PRODUCT: TOSOH ST AIA-PACK TT3, catalog #025282. This reagent is used for the quantitative measurement of Total Triiodothyronine Human Serum. Each box of product contains 5 trays of 20 test cups per tray. Each tray is packaged in a foil pack. Both the box and foil packs have product labels, Recall # Z-0558-06

REASON: The inner foil packs of AIA-PACK ST TT3, Lot FX17440 contain an incorrect expiration date of 10/2005. The outer box is labeled with the correct expiration date of 10/2006.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 22, 2006:

CLASS II

MANUFACTURER: General Electric Med Systems LLC, Waukesha, WI, by letter on December 30, 2004 and site visit thereafter. Firm initiated recall is complete.

PRODUCT: a) Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator’s console, Recall # Z-0219-05; b) Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; wall stand; overhead tube suspension; operator console and digital archive system, Recall # Z-0220-05

REASON: Units had a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.

MANUFACTURER: Cardiac Science, Inc., Minnetonka, MN, by telephone or letter dated February 2, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Powerheart AED G3 Automated External Defibrillator Model 9300E. Recall # Z-0398-05; b) Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Recall # Z-0399-05; c) Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series), Recall # Z-0400-05

REASON: AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not function properly and may interfere with the AED’s ability to delivery therapy. In the event that charge noise is present it will delay the first defibrillation shock in the 3 shock sequence.

MANUFACTURER: Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letters dated December 20, 2005. Manufacturer: Fisher Diagnostic, a Company of Fisher Scientific LLC, Middletown, VA. Firm initiated recall is ongoing.

PRODUCT: Architect Stat Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent, Recall # Z-0513-06

REASON: There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.

MANUFACTURER: Recalling Firm: Hamilton Co., Reno, NV, by letters on December 15, 2005. Manufacturer: Hamilton Bonaduz, Bonaduz, Switzerland. Firm initiated recall is ongoing.

PRODUCT: Microlab AT, part numbers 135001, 135001OOC, 135002, 135003, 135005, 135006, 135006R, 135007, 135008, 135016, 135028, 135029, 936400, 936400BLU. Microlab AT+ and Microlab AT+2, part numbers 142000, 142001, 142001R, 142002, 142003, 142005, 142006, 142006R, 142007, 142008, 142009, 142015, 142017, 142035, 142036, Recall # Z-0514-06

REASON: Heat sinking on power boards may not operate as intended and the board may cease to operate.

MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter on January 3, 2006. Manufacturer: Draeger Medical AG & Co., Lubeck, Germany. Firm initiated recall is ongoing.

PRODUCT: Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator. Catalog numbers 8418300, 8411162, 8418002, and 8418000, Recall # Z-0515-06

REASON: Failure to generate an alarm when an unintended disconnection occurs.

MANUFACTURER: Recalling Firm: Abbott Laboratories Diagnostic Div, South Pasadena, CA, by letter on December 27, 2005. Manufacturer: Medical Analysis Systems Inc., Camarillo, CA, Firm initiated recall is ongoing.

PRODUCT: Clinical Chemistry Multiconstituent Calibrator, List number: lE65-02, Recall # Z-0516-06

REASON: The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened expiration dating, two lots are now expired. The expiration date for Lot number 26674M100 will be revised from 2006-07-31 to 2006-01-31.

MANUFACTURER: Spacelabs Medical Incorporated, Issaquah, WA, by telephone on July 20, 2005. Firm initiated recall is ongoing.

PRODUCT: Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. Recall # Z-0517-06

REASON: The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes.

MANUFACTURER: Sunrise Medical, Fresno, CA, by telephone and letter on November 9, 2005. Firm initiated recall is complete.

PRODUCT: Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair, Recall # Z-0518-06

REASON: While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.

MANUFACTURER: Recalling Firm: Gish Biomedical Inc, Rancho Santa Margarita, CA, by letter on November 14, 2005. Manufacturer: Sunrise Medical Inc, Fresno, CA. Firm initiated recall is ongoing.

PRODUCT: The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood. Recall # Z-0519-06

REASON: Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported.

MANUFACTURER: Kinetic Concepts, Inc., San Antonio, TX, by letter on January 24, 2005. Firm initiated recall is complete.

PRODUCT: RotoProne powered patient rotation bed, part #209500, Recall # Z-0520-06

REASON: To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.

MANUFACTURER: Tung Keng Enterprise Co., Ltd., Tai-Tzu Hsiang, Taiwan, Republic of China, by letters on November 1, 2005. Firm initiated recall is ongoing.

PRODUCT: a) The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue base. The red base is identified with SKU #9153641905. The blue base is identified with SKU #9153641906. Recall # Z-0521-06; b) The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains either a red or blue base. The red base is identified with SKU #915363224. The blue base is identified with SKU #915363225. Recall # Z-0522-06

REASON: The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.

MANUFACTURER: Wright Medical Technology Inc., Arlington, TN, by letter dated January 10, 2005. Firm initiated recall is ongoing.

PRODUCT: Guardianâ Distal Femur Axial Pin, Recall # Z-0523-06

REASON: The product was not fully assembled prior to packaging.

MANUFACTURER: Diagnostic Products Corp, Los Angeles, CA, by telephone starting on January 5, 2005, and by e-mail or Fax starting on January 3, 2005. Firm initiated recall is ongoing.

PRODUCT: IMMULITE 2000 Total Testosterone Kit, Catalog Numbers: L2KTW and L2KTW, Recall # Z-0528-06

REASON: The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol concentration.

MANUFACTURER: Recalling Firm: Lumenis, Inc., Santa Clara, CA, by letters on April 8, 2005. Manufacturer: Lumenis, Ltd., Yokneam, Israel. Firm initiated recall is complete.

PRODUCT: Lumenis brand Lumenis One System with Multi-Spot Nd: YAG, LightSheer and Universal IPL, Recall # Z-0529-06

REASON: Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.

MANUFACTURER: Depuy Orthopedics, Inc. Warsaw, IN, by letter dated November 10, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Depuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000, Recall # Z-0530-06; b) Depuy brand Acclaim Elbow linked ulnar bearing, assembly (ulnar bearing and locking screw), sterile; catalog # 1722-63-000, Recall # Z-0531-06

REASON: The ulnar bearing may damage the implant’s polyethylene sleeve such that revision surgery is necessary.

MANUFACTURER: Recalling Firm: Medtronic, Inc., Fridley, MN, by press release and letters on November 29, 2005. Manufacturer: Madtronic Med Rel Inc, Humacao, PR, Firm initiated recall is ongoing.

PRODUCT: a) Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303, Recall # Z-0534-06; b) Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306, Recall # Z-0535-06; c) Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303, Recall # Z-0536-06; d) Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303, Recall # Z-0537-06; e) Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker, models SSR203, SSR303, SSR306, Recall # Z-0538-06; f) Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only, Recall # Z-0539-06

REASON: An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 15, 2006:

CLASS I

MANUFACTURER: Recalling Firm: RC2 Brands Inc., The First Years, Stoughton, MA, by letters on January 27, 2006. Manufacturer: Yi Shing Co. Ltd, Hong Kong, China. Firm initiated recall is ongoing.

PRODUCT: a) Disney Days Hunny Cool Ring Teether Style # Y1447, Recall # Z-0455-06; b) Disney Baby Sift Cool Ring Teether Style # Y1470, Recall # Z-0456-06; c) Disney Baby Soft Cool Ring Teether Style # Y1490, Recall # Z-0457-06; d) The First Years Cool Animal Teether/Fish, Zebra and Dinosaur designs Style # Y1473, Recall # Z-0458-06; e) The First Years Floating Friend Teether Style # Y1474, Recall # Z-0459-06; f) Sesame Beginnings Chill & Chew Teether Style # Y3095, Recall # Z-0460-06

REASON: Liquid filled infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida.

CLASS II

MANUFACTURER: Recalling Firm: Ethicon, Inc., Somerville, NJ, by letter on January 4, 2006. Manufacturer: Ethicon, Inc., Cornelia, GA. Firm initiated recall is ongoing.

PRODUCT: PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer. Recall # Z-0449-06

REASON: Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.

MANUFACTURER: Recalling Firm: Abbott Spine, Austin, TX, by telephone and letters on or about November 2, 2005. Manufacturer: RMS Company, Minneapolis, MN. Firm initiated recall is ongoing.

PRODUCT: TraXis Vue Spinal Implant System, Part #2601-090921. Recall # Z-0502-06

REASON: Implants were manufactured without radiographic markers.

MANUFACTURER: Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated December 1, 2005. Manufacturer: Hudson Respiratory Care, Inc., Arlington Heights, IL. Firm initiated recall is ongoing.

PRODUCT: AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; catalog #037-00, Recall # Z-0503-06

REASON: Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements.

MANUFACTURER: Hospira Inc., Lake Forest, IL, by letter dated January 9, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Hospira Latex Free Blood Secondary Set, 26 inch with Secure Lock; Made in Costa Rica, list 4602-58, Recall # Z-0504-06; b) LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 inch, with Backcheck Valve and 2 Clave Ports, Piggyback with Option-Lok; Made in Costa Rica, list 19229-48, Recall # Z-0505-06; c) Hospira Transpac IV Monitoring Kit, 60 inch disposable transducer monitoring kit with second stopcock by transducer, continuous flush device and drip chamber; Made in Costa Rica, list 42584-04-05, Recall # Z-0506-06

REASON: The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated January 10, 2006. Manufacturer: Baxter Healthcare Corporation, Cleveland, MS. Firm initiated recall is ongoing.

PRODUCT: a) Baxter Continuous Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the epidural needle and catheter; Recall # Z-0507-06; b) Baxter Combined Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing a spinal needle, an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the spinal needle or epidural needle and catheter, Recall # Z-0508-06; c) Baxter Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the epidural needle and catheter, Recall # Z-0509-06

REASON: The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.

MANUFACTURER: Boston Scientific Corporation, Spencer, IN, by letter dated December 20, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 1.9 Fr., sterile, latex free; Catalog no. 390-104, Recall # Z-0510-06; b) Boston Scientific brand Zero Tip Nitinol Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr., sterile, latex free; Catalog no. 390-105, Recall # Z-0511-06

REASON: The basket wire assembly may detach from the drive wire while in the patient.

MANUFACTURER: Roche Diagnostics Corporation, Indianapolis, IN, by letter dated January 31, 2006. Firm initiated recall is ongoing.

PRODUCT: Elecsys Troponin T; catalog number 2017644, Recall # Z-0512-06

REASON: A false negative result may be reported.

CLASS III

MANUFACTURER: Regeneration Technologies, Inc., Alachua, FL, by letter on October 14, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Product is 1.0 cc Regenaform® RT. SINGLE PATIENT USE ONLY. Recall # Z-0481-06; b) OPTEFORM Allografts of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0482-06; c) Product is OPTEFORM Allograft Paste of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0483-06; d) OPTEFORM® RT Moldable Allograft of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0484-06; e) Osteofil + RT Allograft Paste in varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0485-06; f) Osteofil Allograft Paste (Bio) of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0486-06; g) Osteofil IC Syringeable of varying sizes. SINGLE PATIENT USE ONLY. Recall # 0487-06; h) Osteofil ICM Moldable Strip of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0488-06; i) Osteofil RT, ICM Allograft Paste of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0489-06; j) OSTEOFIL® DBM Paste of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0490-06; k) OsteoPack 3 FZ 22cc. SINGLE PATIENT USE ONLY. Recall # Z-0491-06; l) Regenafil IC. SINGLE PATIENT USE ONLY. Recall # Z-0492-06; m) REGENAFORM RT Allograft Paste, 1cc. SINGLE PATIENT USE ONLY. Recall # Z-0493-06; n) Product is REGENAFORM® Allograft Moldable Blocks, of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0494-06; o) Product is RTI Allograft Paste of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0495-06; p) Product is REGENAFIL® Allograft Paste, Syringe, 0.5cc. SINGLE PATIENT USE ONLY. Recall # 0496-06; q) Product is 1.0cc flowable paste from donor approved for distribution in Italy. SINGLE PATIENT USE ONLY. Recall # Z-0497-06; r) Product is OPTEFIL Allograft Paste of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0498-06; s) Product is OPTEFIL Allograft Paste, Syringe of varying sizes. SINGLE PATIENT USE ONLY. Recall # Z-0499-06; t) Product is OPTEFORM® Allograft Full Disc, 5 x 90mm, 32cc, Frozen. SINGLE PATIENT USE ONLY, Recall # Z-0500-06; u) Product is 2.0 cc Opteform® RT. SINGLE PATIENT USE ONLY. Recall # Z-0501-06

REASON: The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 8, 2006:

CLASS I

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, San Diego, CA, by letter on January 26, 2006. Manufacturer: Boston Scientific Corporation, Letterkenny, Ireland. Firm initiated recall is ongoing.

PRODUCT: The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. This process, referred to as AtherotomyQ3J, allows dilatation of the target lesion with less pressure. The device is provided in 6 mm, 10 mm, and 15 mm lengths. The working length is the distance between the radiopaque marker bands. The proximal catheter shaft of the Flextome Cutting Balloon Device is a hypotube. This hypotube contains the inflation lumen for the balloon. The distal shaft is made of flexible material and contains two lumens. One lumen is for balloon inflation, and the second lumen is a guidewire lumen. The distal shaft is coated with a hydrophilic coating. The guidewire lumen is colored green for greater visibility. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchanges. A needle with a luer port is included for flushing the wire lumen prior to the insertion of appropriate coronary guide wires. CLIPIT1M clips are provided to aid in handling of the catheter. Recall #Z-0409-06

REASON: The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., RoundLake, IL, by letter on December 13, 2005. Manufacturer: Baxter Healthcare Corp., Singapore. Firm initiated recall is ongoing.

PRODUCT: a) Baxter Colleague Single Channel Volumetric Infusion Pumps; product codes 2M8151, 2M8151R, BRM8151(Brazilian Portugese), DNM8151(French), HNM8151(German), PNM8151(Spanish), CNM8151 (Swedish), GNM8151(Danish), TRM8151(Turkish), WNM8151(Dutch) , 2M8161, 2M8161R, Recall # Z-0444-06; b) Baxter Colleague Triple Channel Volumetric Infusion Pumps; product codes 2M8153, 2M8153R, BRM8153(Brazilian Portugese), DNM8153(French), HNM8153(German), PNM8153(Spanish), CNM8153 (Swedish), GNM8153(Danish), TRM8153(Turkish), WNM8153(Dutch) ,2M8163, 2M8163R, Recall # Z-0445-06

REASON: Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to IV administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components.

CLASS II

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., RoundLake, IL, by letters dated May 5, 2005. Manufacturer: Baxter Healthcare Corp., Singapore. Firm initiated recall is ongoing.

PRODUCT: Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550, Recall # Z-0159-06

REASON: A “Check Flange” alarm may occur even though the syringe has been properly loaded into the AS50 Infusion Pump. The false alarm may occur during the syringe loading process or while an infusion is running. Also, the occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, San Diego, CA, by letter on January 26, 2006. Manufacturer: Boston Scientific Corporation, Letterkenny, Ireland. Firm initiated recall is ongoing.

PRODUCT: The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty(PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure. Recall # Z-0410-06

REASON: The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated November 7, 2005. Manufacturer: Baxter Healthcare Corp., Singapore. Firm initiated recall is ongoing.

PRODUCT: Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I, Recall # Z-0411-06

REASON: Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated November 14, 2005. Manufacturer: Baxter Healthcare Corp., Singapore. Firm initiated recall is ongoing.

PRODUCT: Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Recall # Z-0412-06

REASON: Failures within the PCA profile as well as incidents resulting in interruptions of therapy in various profiles.

MANUFACTURER: Manufacturer: Omron Healthcare, Inc., Vernon Hills, IL, by letters dated October 21, 2005 and by press release on October 24, 2005. Manufacturer: Ionics EMS, Inc, Cabuyao, Philippines. Firm initiated recall is ongoing.

PRODUCT: Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature measurement in 4-6 seconds typically in the oral, rectal or under arm modes when the ambient temperature is between 50 degrees F and 93.2 degrees F; UPC 73796-43600, Recall # Z-0466-06

REASON: Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on November 17, 2005. Manufacturer: Becton Dickinson P R, Inc, Juncos, PR. Firm initiated recall is ongoing.

PRODUCT: a) BD Perisafe catheter with catheter connector. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. It is allocated to be packaged and sold in kits, trays, Perisafe and bulk. Reorder Number 400507, Recall # Z-0467-06; b) BD Perisafe epidural mini-kit: 18 G x 3 1/2 in. Weiss needle. The catheter connector has four components: body (green), cap (white), washer (white), and gasket (grey). It is used for continuous administration of anesthesia. It is allocated to be packaged and sold in kits, trays, Perisafe and bulk. Reorder Number 400273, Recall # Z-0468-06

REASON: The catheter connector could not be sufficiently tightened to secure the catheter tubing.

MANUFACTURER: Recalling Firm: AGFA Corp, Greenville, SC, by telephone and letter on/about December 21, 2005. Manufacturer: AGFA Corp., Goose Creek, SC. Firm initiated recall is ongoing.

PRODUCT: Agfa Cronex™ 10T Radiographic film. Catalog number LF5D1, Recall # Z-0471-06

REASON: Mislabeling; Product labeled Cronex™ 10T actually contains Afga, Curix Ultra UVL Plus.

MANUFACTURER: QLT USA, Inc., Fort Collins, CO, by letter on January 26, 2006. Firm initiated recall is ongoing.

PRODUCT: Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile, Recall # Z-0476-06

REASON: Injectable needles were included in procedure kits instead of sterile blunt cannulas.

MANUFACTURER: Cryolife Inc, Kennesaw, GA, by letter dated May 11, or May 12, 2004. Firm initiated recall is ongoing.

PRODUCT: a) CryoValve, Pulmonary Valve & Conduit, Recall # Z-0477-06; b) CryoValve, Aortic Valve & Conduit, Recall # Z-0478-06; c) CryoValve, Pulmonary Valve & Conduit - SG, Recall # Z-0479-06

REASON: During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.

MANUFACTURER: Cryolife Inc, Kennesaw, GA, by letters on January 25, 2006. Firm initiated recall is ongoing.

PRODUCT: CryoValve, Pulmonary Valve & Conduit, Donor number 78142, Model number PV00, Recall # Z-0480-06

REASON: Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.

CLASS III

MANUFACTURER: AGA Medical Corp., Golden Valley, MN, by email beginning September 6, 2005. Firm initiated recall is ongoing.

PRODUCT: a) AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile EO. Single Use Only. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication. Recall # Z-0461-06 b) AMPLATZER Duct Occluder, Order No. 9-PDA-004, Device Size 6/4mm, Length 7 mm. Sterile EO. Single Use Only. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication. Recall # Z-0462-06; c) AMPLATZER Duct Occluder, Order No. 9-PDA-005, Device Size 8/6mm, Length 7 mm. Sterile EO. Single Use Only. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication. Recall Z-0463-06; d) AMPLATZER Duct Occluder, Order No. 9-PDA-006, Device Size 10/8mm, Length 8 mm. Sterile EO. Single Use Only. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication. Recall # Z-0464-06; e) AMPLATZER Duct Occluder, Order No. 9-PDA-007, Device Size 12/10mm, Length 8 mm. Sterile EO. Single Use Only. The AMPLATZER Duct Occluder is a self-expandable device made from a Nitinol wire mesh. A retention skirt on the aortic side provides secure positioning in the ampulla of the ductus. As the occluder is implanted, it expands outward and the wires push against the wall of the ductus. Polyester fabric is sewn into the occluder with polyester thread. The fabric induces thrombosis that closes the communication. Recall Z-0465-06

REASON: The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream.

MANUFACTURER: Possis Medical, Inc., Minneapolis, MN, by email on December 12, 2005. Firm initiated recall is ongoing.

PRODUCT: AngioJet XMI Rapid Exchange+, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Model number: 105421-002, Recall # Z-0469-06

REASON: The catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model.

MANUFACTURER: Chembio Diagnostic Systems, Inc., Medford, NY, by telephone and letters dated December 15, 2005 and response forms on December 22, 2005. Firm initiated recall is ongoing.

PRODUCT: Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A?A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml. Recall # Z-0470-06

REASON: Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.

MANUFACTURER: Boston Scientific Corp, San Jose, CA, by letters on December 30, 2005. Firm initiated recall is ongoing.

PRODUCT: Cilli II Cooled Ablation Catheter, Model M00490310, Recall # Z-0473-06

REASON: Product is mislabeled with the incorrect catheter curve description.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter the week of December 19, 2005. Firm initiated recall is ongoing.

PRODUCT: a) OULTER LH 700 Series Hematology Analyzer, PN 6605632 and 6605632R, Recall # Z-0474-06; b) COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R Recall # Z-0475-06

REASON: There is a risk of sample misidentification when processing samples in the Manual aspiration mode.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 1, 2006:

CLASS II

MANUFACTURER: Recalling Firm: General Electric Medical Systems LLC, Waukesha, WI, by letter on April 18, 2005. Manufacturer: General Electric Medical Systems F.I. Haifa, Tirat Hacarmel, Israel. Firm initiated recall is ongoing.

PRODUCT: a) GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized nulear imaging system. It is comprised of 2 digital CSE (Coorelated Signal Enhancement) detectors in variable geometries mounted on a pass-through ring gantry, a compact imaging table, and a GENIE Acquisition station. Recall # Z-0413-06; b) GE Millennium Systems: MG. Multi-Geometry Digital CSE Dual Detector Gamma Camera. A modular nuclear medicine imaging system. The MG gantry allows the detectors to be oriented in the 180-degree and 101.25-degree orientations. The other modular core components include a 3-axis universal imaging table, a GENIE Acquistion station, dual Digital CSE (Correlated Signal Enhancement) detectors and high-performance collimators. Features optional real-time body-contoured SPECT and whole body scans, as well as ACuscan, an optional transmission attenuation correction system for SPeC and Gated SPECT scans. Recall # Z-0414-06; c) GE Millennium Systems: MPR and MPS Digital CSE Single Detector Gamma Camera. This system is a multi-purpose single-head nuclear medicine imaging system, comprised of a Digital CSE (Correlated Signal Enhancement) multi-purpose square detector, a pass-through counter-balanced ring gantry, a SPECT-optimized imaging table, and a collimator cart. Recall # Z-0415-06

REASON: In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could eventually cause the locking mechanism to unlock itself.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letters dated November 9, 2005 and press release issued on January 17, 2006. Manufacturer: Sanmina SCI, Huntsville, AL. Firm initiated recall is ongoing.

PRODUCT: a) Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.), Recall # Z-0417-06; b) Roche brand Accu-Chek Aviva Meter Only Kit; Catalog number 04532279001. (Distributed within the U.S.), Recall # Z-0418-06; c) Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within the U.S.), Recall # Z-0419-06; d) Roche brand Accu-Chek Aviva Retail Distributor Pack; Catalog number 04578198001. (Distributed within the U.S.), Recall # Z-0420-06; e) Roche brand Accu-Chek Aviva Bonus Pack Display; Catalog number 045659066001. (Distributed within the U.S.) Recall # Z-0421-06; f) Roche brand Accu-Chek Aviva Pediatrics Kit; Catalog number 04593839001. (Distributed within the U.S.) Recall # Z-0422-06; g) Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within the U.S.) Recall # Z-0423-06; h) Roche brand Accu-Chek Aviva Care Kit; Catalog number 04422058170; - Canada Catalog number 04422058164; - Nordics Catalog number 04422040170. (Distributed outside of the U.S.) Recall # Z-0424-06; i) Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532356001. (Distributed outside of the U.S.) Recall # Z-0425-06; j) Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.) Recall # Z-0426-06

REASON: Incorrect patient blood glucose test results may be reported due to a software problem.

MANUFACTURER: Instrumentation Industries, Inc., Bethel Park, PA, by telephone on October 14 and 17, 2005 and by letters on October 17 and 18, 2005. Firm initiated recall is ongoing.

PRODUCT: Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30, Recall # Z-0427-06

REASON: Potential for the flexible tube portion of the assembly to become brittle and break.

MANUFACTURER: Hitachi Medical Systems America, Inc., Twinsburg, OH, by letter, dated December 1, 2005. Firm initiated recall is ongoing.

PRODUCT: a) The AIRIS MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagital, oblique, and curved cross-sectional images that display the internal structure of the head, body, and extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance and proton density, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. Recall # Z-0428-06; b) The AIRIS II MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagital, oblique, and curved cross- sectional images that display the internal structure of the head, body, and extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance and proton density, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. Recall # Z-0429-06 REASON: The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.

MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Sparks, MD, by telephone, fax and email on December 1, 2005. Manufacturer: GFS Chemicals Inc., Columbus, OH. Firm initiated recall is ongoing.

PRODUCT: BD™ PhoenixSpec™ Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit calibrators, Recall # Z-0430-06

REASON: A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity.

MANUFACTURER: Lifescan, Inc., Milpitas, CA, by letter on November 21, 2005. Firm initiated recall is ongoing.

PRODUCT: LifeScan One Touch Ultra Test strips, part number 020-245-07, Recall # Z-0435-06

REASON: Product may be defective and may give low inaccurate glucose results.

MANUFACTURER: Smiths Medical PM, Inc., Waukesha, WI, by a Safety Action Bulletin, number 05-SAB05, dated 12/05/05. Firm initiated recall is ongoing.

PRODUCT: Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency. Recall # Z-0436-06

REASON: A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.

MANUFACTURER: Datascope Corp., Mahwah, NJ, by letters on December 7, 2005. Firm initiated recall is ongoing.

PRODUCT: Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor, Recall # Z-0437-06

REASON: Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on December 12, 2005. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.

PRODUCT: a) Arcadic Orbic Mobile X-Ray System, model number 8081080, Recall # Z-0438-06; b) Arcadis Varic Mobile X-Ray System, model number 8080017, Recall # Z-0439-06

REASON: Patient information can be stored in another patient’s file.

MANUFACTURER: Ev3, Inc., Plymouth, MN, by letter on August 1, 2005. Firm initiated recall is complete.

PRODUCT: Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75, Recall # Z-0442-06

REASON: A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.

MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Sparks, MD, by letter on January 17, 2006. Manufacturer: Hach Chemical Company, Loveland, CO. Firm initiated recall is ongoing.

PRODUCT: BM™ PhoenixSpec™ Nephelometer, Catalog # 440910. Recall # Z-0443-06

REASON: A operator’s manual for a diagnostic test kit is incorrect and may cause inaccurate results for bacterial identification and antibiotic susceptibility in patient samples.

MANUFACTURER: Recalling Firm: Depuy Mitek, a Johnson & Johnson Co., Raynham, MA, by letter on October 27, 2005. Manufacturer: Ethicon SARL, Neuchatel, Switzerland. Firm initiated recall is complete.

PRODUCT: Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740, Recall # Z-0446-06

REASON: The device may contain one strand of suture instead of two strands.

MANUFACTURER: Recalling Firm: Wahl Clipper Corporation, Sterling, IL, by letters dated October 31, 2005. Manufacturer: Wahl Clipper Ningbo Ltd, Zhejiang, China. Firm initiated recall is ongoing.

PRODUCT: a) Wahl 2-Speed All-Body Massager, model 4120-1; therapeutic massager; made in China; Please note: Wahl sells these massagers under other model numbers based on the packaging configuration. All packages contain the model 4120-1 massager, with various attachments. These package models include 4120-200 and 4120-217, Recall # Z-0447-06; b) Wahl 2-Speed All-Body Massager with Heat and Discovery Channel brand 8-Way Massager with Heat, model 4196-1; therapeutic massager; made in China; Please note: Wahl sells these massagers under other model numbers based on the packaging configuration. All packages contain the model 4196-1 massager, with various attachments. These package models include 4196-500, 4196-517 and 4196-519, Recall # Z-0448-06

REASON: The massager may develop a crack in the cord insulation where it exits out of the strain relief. A crack in the insulation may expose live conductors resulting in a possible electric shock and injury to the user.

MANUFACTURER: Recalling Firm: Ethicon, Inc., Somerville, NJ, by letter on January 4, 2006. Manufacturer: Ethicon, Inc., Cornelia, GA. Firm initiated recall is ongoing.

PRODUCT: PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer. Recall # Z-0449-06

REASON: Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.

CLASS III

MANUFACTURER: Recalling Firm: Abbott Molecular, Des Plaines, IL, by letters on October 28, 2005. Manufacturer: Vysis Inc., Downers Grove, IL. Firm initiated recall is ongoing.

PRODUCT: Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; order number 32-190078, Recall # Z-0416-06

REASON: The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region.

MANUFACTURER: Recalling Firm: Integra LifeSciences Corpoation, Plainsboro, NJ, by letters on November 28, 2005. Manufacturer: Integra Neurosciences Ltd., Andover, United Kingdom. Firm initiated recall is ongoing.

PRODUCT: Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set. Recall # Z-0431-06

REASON: Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by letter on May 28, 2005. Firm initiated recall is complete.

PRODUCT: a) Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Product UPN H749343565830, Recall # Z-0432-06; b) Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Product UPN H749343566850, Recall # Z-0433-06

REASON: Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style.

MANUFACTURER: Tnco, Inc., Whitman, MA, by telephone and letter on January 2, 2006. Firm initiated recall is ongoing.

PRODUCT: Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A) Non-sterile, Reusable Stainless Steel Surgical Instrument Part Number: 125382A, Recall # Z-0434-06

REASON: The tip may not engage with the handle and may dislodge.

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by letter on May 14, 2004. Firm initiated recall is complete. \PRODUCT: Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). The stent is constrained within a 6F delivery system. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. An inner shaft, with two radiopaque markers, aids in the placement of the stent. The delivery system is compatible with 0.035 in. (0.89mm) guidewires. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. As the stent is exposed to body temperature it expands to appose the duct wall. UPN # H7493894886070, Recall # Z-0440-06

REASON: One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package.

MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by letter on January 5, 2006. Firm initiated recall is ongoing.

PRODUCT: SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable, Recall # Z-0441-06

REASON: The dilator size does not match the label on the product and product packaging.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 25, 2006:

CLASS I

MANUFACTURER: Vapotherm, Inc, Stevensville, MD, by letters on October 13, 2005, October 31, 2005, November 4, 2005, December 20, 2005 and December 22, 2005. Firm initiated recall is ongoing.

PRODUCT: Vapotherm™ Respiratory Gas Humidifier, Model 2000i, Recall # Z-0360-06

REASON: Vapotherm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners.

CLASS II *****CORRECTION***** In the November 16, 2005 Enforcement Report, 05-46, the VITROS ECi /EciQ System Recall # Z-0137-06 -- CODE The recall applies to systems with software below Version 3.1 and not software version 3.1 or lower.

MANUFACTURER: Recalling Firm: Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN, by letters on November 30, 2005 and December 5, 2005.

Manufacturer: Medtronic Puerto Rico Inc., Villalba, PR. Firm initiated recall is ongoing.

PRODUCT: Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model 7428 Kinetra Neurostimulator; Models 3387, 3389 DBS Leads; and Models 7482,7495 DBS Extensions. Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via Extension and Lead. These components comprise the implantable portion of the Activa System, Recall # Z-0370-06

REASON: A safety concern exists regarding the Medtronic Activa Deep Brain Stimulation system instructions for performing MRI (magnetic resonance imaging). Medtronic's instructions have until now recommended a use of a displayed MRI head specific absorption rate (SAR) of not more than 0.4 W/kg. To maintain the intended tissue heating safety margin, the recommended maximum displayed head SAR is now 0.1 W/kg.

MANUFACTURER: Smith & Nephew Inc., Endoscopy Division, Mansfield, MA, by letter on July 1, 2005. Firm initiated recall is ongoing.

PRODUCT: Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) Reference number: 7210430, Recall # Z-0371-06

REASON: Drill does not contain laser etched depth marks to assure proper depth of inserted device.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on December 5, 2005. Manufacturer: Becton Dickinson Preanalytical Solutions, Sumter, SC. Firm initiated recall is ongoing.

PRODUCT: BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder, Recall # Z-0372-06

REASON: Cracked finger grip luer adapter components on the Push Button Blood Collection Set.

MANUFACTURER: Kimberly-Clark Corporation, Roswell, GA, by letter on November 30, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Kimberly-Clark/Ballard TRACH CARE* - 72 Closed Suction products for Adults, Rx Only, Sterile * Diameter 14 Fr (4.6 mm), 54 cm (21.3 in) * Single Use * Made in Mexico, Catalog number 227, Recall # Z-0373-06; b) Kimberly-Clark/Ballard TRACH CARE* - 72 Wet Pak* for Adults * Closed Suction System with Saline Vials * Diameter 14 Fr (4.6 mm), Length 30.5 cm (12 in) * Rx Only * Single Use, Catalog number 8308, Recall # Z-0374-06; c) Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) * Single Use, Recall # Z-0375-06

REASON: The integrity of the sterile unit package may become compromised.

MANUFACTURER: Boston Scientific Corp, Spencer, IN, by letter dated December 8, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes; Catalog No. 1640, Order No. M00516401. Recall # Z-0376-06; b) Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package of 10 brushes; Catalog No. 1650, Order No M00516501, Recall # Z-0377-06;

REASON: The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.

MANUFACTURER: Instrumentation Laboratory Co., Lexington, MA, by letter dated December 16, 2005. Firm initiated recall is ongoing.

PRODUCT: GEM PREMIER 3000, Point-of-care blood analyzer. Recall # Z-0378-06

REASON: Software error may report higher results for glucose and lactate.

MANUFACTURER: Recalling Firm: Beckman Coulter Inc, Brea, CA, by letter on November 28, 2005. Manufacturer: Applied Cytometry Systems, Dinnington, United Kingdom. Firm initiated recall is ongoing.

PRODUCT: Cytomics FC500 Cytometer with CXP Software, Part Numbers 629636 629637, Recall # Z-0380-06

REASON: Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0.

MANUFACTURER: Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter and Field Modification Instructions FMI 74024 and FMI 71016A beginning on September 2, 2004. Manufacturer: General Electric Med Systems China Co., Ltd., Wuxi, Jiangsu, China. Firm initiated recall is ongoing.

PRODUCT: a) GE LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477, Recall # Z-0386-06; b) GE LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935, Recall # Z-0387-06

REASON: The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next patient.

MANUFACTURER: Recalling Firm: Ossur, Reykjavik, Ireland, by telephone and letters on October 21, 2005. Manufacturer: Ossur North America Inc., Aliso Viejo, CA. Firm initiated recall is ongoing.

PRODUCT: Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR, Recall # Z-0388-06

REASON: After one year devices assembled with a new type of O-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot.

MANUFACTURER: Hospira Inc, Morgan Hill, CA, by letters on May 18, 2005. Firm initiated recall is ongoing.

PRODUCT: Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets, Recall # Z-0389-06

REASON: The pump may shut-off prematurely during battery operation without providing adequate response time when 'E320' service warning message appears.

MANUFACTURER: Cook Inc, Bloomington, IN, by telephone October 24, 2005 and January 6, 2006. Firm initiated recall is ongoing.

PRODUCT: a) Cook brand Zilver 635 Biliary Stent -- Expanding Stent, delivery system length 80 cm, stent diameter 7.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-7.0-40. Recall # Z-0390-06; b) Cook brand Zilver 635 Biliary Stent -- Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length 60 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-6.0-60, Recal # Z-0391-06

REASON: The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. The label front is correct.

MANUFACTURER: Varian Medical Systems, Palo Alto, CA, by letters on November 23, 2005. Firm initiated recall is ongoing.

PRODUCT: Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acuity (used with BrainLab M3 MLC); Product Number 83 (used with Product Number 53); Product Number 48 (used with Product Number 53); Product Number 77 (used with Product Number 53); Recall # Z-0393-06

REASON: The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment. If the treatment plan called for multiple MLC leaf positions then a mistreatment could occur, since the MLC leaves would not change as expected.

MANUFACTURER: Smiths Medical ASD, Inc., Gary, IN, by letters on December 16, 2005. Firm initiated recall is ongoing. PRODUCT: a) Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60, Recall # Z-0394-06; b) Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80, Recall # Z-0395-06; c) Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 130 mm; REF 67HA80, Recall # Z-0396-06

REASON: Sterility is compromised by incomplete package seal.

MANUFACTURER: Stentor, Inc., Brisban, CA, by letters on December 20, 2005. Firm initiated recall is ongoing.

PRODUCT: "iSite" PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3, Recall # Z-0399-06

REASON: When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the patient/exam selected and shown may be different on the radiologist console and diagnostic display screens.

MANUFACTURER: CooperSurgical, Inc., Trumbull, CT, by telephone and letter dated November 3, 2005. Firm initiated recall is ongoing.

PRODUCT: Milex 60cc Handy-Vak Locking Syringe Ref: MX500, Recall # Z-0401-06

REASON: Potential for the plunger to separate from the piston.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on October 25, 2005. Manufacturer: Becton Dickinson Medical - Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.

PRODUCT: a) BD 1 mL BD Safety Glide tuberculin syringe with 27 G x 1/2 in. BD needle, Reference Number 305945: 1mL 27G Blister, Recall # Z-0402-06; b) D 1 mL BD Safety Glide Tuberculin syringe with 26 G x 3/8 in. BD needle, Reference Number 305946: Product Description: 1ml 26G Blister, Recall # Z-0403-06; c) BD 1 mL Allergist tray with 27 G x 1/2 in. BD Safety Glide. Reference Number 305950: Product Description: 1 mL 27G Allergist Tray, Recall # Z-0404-06; d) BD 1 mL Allergist tray with 26G x 3/8 in. BD Safety Glide, Reference Number 305951: Product Description: 1 mL 26G Allergist tray, Recall # Z-0405-06

REASON: Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.

MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Sparks, MD, by letter on November 23, 2005. Manufacturer: Becton Dickinson Caribe LTD, Cayey, PR. Firm initiated recall is ongoing.

PRODUCT: BBL™ GasPak™ Pouch System and BBL™ GasPak™ CampyPouch™ System, Catalog numbers 260651 and 260656, packed in boxes of 25, Recall # Z-0406-06

REASON: Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples.

CLASS III

MANUFACTURER: Vygon Neuro, Norristown, PA, by letter on March 24, 2005 . Firm initiated recall is complete.

PRODUCT: a) 6 cm Catheter Reservoir with 10 cm extension, Recall # Z-0365-06; b) 7 cm Catheter Reservoir with 10 cm extension, Recall # Z-0366-06; c) 10 cm Scopable Catheter Reservoir, Recall # Z-0367-06

REASON: Stylet in package is shorter than that claimed on the label.

MANUFACTURER: Cook, Inc., Bloomington, IN, by telephone and letter dated September 26, 2005. Firm initiated recall is complete.

PRODUCT: Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038" (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038" end hole; Reorder # MWCE-38-20-20. Recall # Z-0368-06

REASON: The coil is 20 centimeters in length, but the label states the length is 20 millimeters.

MANUFACTURER: Alsius Corporation, Irvine, CA, by letter on November 9, 2005. Firm initiated recall is ongoing.

PRODUCT: Alsius CoolGard Temperature Regulation System, Recall # Z-0369-06

REASON: Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.

MANUFACTURER: Recalling Firm: Kinetic Concepts, Inc., San Antonio, TX, by telephone and letter on September 16, 2005. Manufacturer: Pacific Device De Mexico S A De C V, Tijuana, Mexico. Firm initiated recall is complete.

PRODUCT: V.A.C. ATS Canister with Gel (500 mL), Part # M6275063/10.S, Recall # Z-0379-06

REASON: Possible mislabeling of shipping cartons.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by reagent bulletin dated December 7, 2005. Manufacturer: Roche Diagnostics GmbH, Penzberg, Germany. Firm initiated recall is ongoing.

PRODUCT: a) Roche Elecsys total PSA, catalog number 11731262322, Recall # Z-0381-06; b) Roche Elecsys total PSA CalSet, catalog number 11731696322, Recall # Z-0382-06

REASON: There is a possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.

MANUFACTURER: Abbott Laboratories Diagnostic Div., South Pasadena, CA, by letter on November 10, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Clinical Chemistry Apolipoprotein A1, List Number 9D92-20, Recall # Z-0383-06; b) Clinical Chemistry Immunoglobulin M, List Number 1E01-20, Recall # Z-0384-06; c) Clinical Chemistry Prealbumin, List Number 1E02-20, Recall # Z-0385-06;

REASON: These specific protein assays are not meeting the 57-day on board stability claim.

MANUFACTURER: Recalling Firm: Medtronic Gastroenterology/Urology, Shoreview, MN, by letters on December 14, 2005.

Manufacturer: Catheter and Disposables Technology, Inc., Plymouth, MN. Firm initiated recall is ongoing.

PRODUCT: Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Recall # Z-0392-06

REASON: Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH recorder. Medtronic has determined that patient safety is not compromised, but catheter function may be affected and damage may result to the Digitrapper pH recorder.

MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA, by e-mail on December 2, 2005. Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.

PRODUCT: VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument), Recall # Z-0397-06

REASON: The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happened during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.

MANUFACTURER: Recalling Firm: Abbott Laboratories, Inc, Irving, TX, by letter dated December 8, 2005. Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. Firm initiated recall is ongoing.

PRODUCT: ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, Recall # Z-0398-06

REASON: System software assigns a calibrator default volume of 2.OuL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL.

MANUFACTURER: Recalling Firm: Abbott Laboratories, Abbott Park, IL, by telephone on October 17, 2005. Manufacturer: Fisher Diagnostic, A Company of Fisher Scientific LLC, Middletown, VA. Firm initiated recall is ongoing.

PRODUCT: Architect Stat Myoglobin Calibrators; List 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL, Recall # Z-0400-06

REASON: Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen.

MANUFACTURER: Recalling Firm: SonoSite, Inc., Bothell, WA, by telephone between December 12-19, 2005 and by letter on December 14, 2005. Manufacturer: Contour Plastics, Inc., Baldwin, WI. Firm initiated recall is ongoing.

PRODUCT: SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Each kit is packaged in a hermetically sealed clear plastic pouch with white backing. Product is labeled as Sterile. 24 pouches are packaged in a white cardboard box and labeled as SonoSite L25 Needle Guide Kit, 21 GAUGE REF# P04053-01, Quantity: 24, CONTENTS STERILE IF PACKAGE IS INTACT. Recall # Z-0407-06

REASON: 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.

MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letters on October 26, 2005 and November 10, 2005. Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing.

PRODUCT: STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method. Recall # Z-0408-06

REASON: The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 18, 2006:

CLASS I

MANUFACTURER: Recalling Firm: Ortho-Clinical Diagnostics, Rochester NY, by letters on December 15, 2005. Manufacturer: Ortho-Clinical Diagnostics, Cardiff, UK. Firm initiated recall is ongoing.

PRODUCT: Vitros Immunodiagnostic HbsAg Confirmatory Kit 8 Ref 680 1324, UPC +H221680132412. Each kit contains: 1 x kit of reagents, and protocol card for HbsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit. Recall # Z-0327-06

REASON: Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as “Not Confirmed”.

CLASS II

MANUFACTURER: Integra Neuro Sciences, San Diego, CA, by letter on September 8, 2005. Firm initiated recall is ongoing.

PRODUCT: NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Recall # Z-0339-06

REASON: Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to ± 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of ± 2 mmHg maximum ICP drift within the first 24 hours of monitoring.

MANUFACTURER: Recalling Firm: Boston Scientific Corp, Natick, MA, by letter dated October 28, 2005. Manufacturer: Boston Scientific Corp, Glens Falls, NY. Firm initiated recall is ongoing.

PRODUCT: a) Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter. Boston Scientific Catalog # 45-305, M001453050. Recall # Z-0340-06; b) Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Recall # Z-0341-06; c) Silicone Central Venous Catheters with PASV Valve and Polyester Cuff - 7F. Boston Scientific Cat. #CVC702IK, M001CVC702IKO, Recall # Z-0342-06; d) Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0, Recall # Z-0343-06; e) Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66A M001PRTA66AO, Recall # Z-0344-06

REASON: Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.

MANUFACTURER: Oscor, Inc., Palm Harbor, FL, by letter on September 13, 2005. Firm initiated recall is ongoing.

PRODUCT: Introducer Set. Labeled as "Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)" Catalog # 06607 (Oscor) and 666089-201 (Guidant), Recall # Z-0345-06

REASON: Sheath size is larger than dilator size causing insertion difficulties.

MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by telephone on September 1, 2005 and September 14, 2005. Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ. Firm initiated recall is complete.

PRODUCT: 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton, Recall # Z-0346-06

REASON: Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., McGaw Park, IL, by letters dated November 18, 2005. Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.

PRODUCT: System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA, product codes S1000L3, S1000L3P, S1000LC2, S1000L3T, S1000L3TD, S1000L3PR, ARENASP, ARENASPP, ARENASPX, ARENADPX, Recall # Z-0347-06

REASON: Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air emboli condition.

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by letter on November 7, 2005. Firm initiated recall is ongoing.

PRODUCT: A) IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable, Catalog Number IN1600, Recall # Z-0348-06; b) IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable, Catalog Number IN1600/A, Recall # Z-0349-06; c) IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable. Catalog Number IN1615, Recall # Z-0350-06; d) IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable. Catalog Number IN1615/A, Recall # Z-0351-06

REASON: Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.

MANUFACTURER: Recalling Firm: AGFA Corp, Greenville, SC, by letter on/about December 1, 2005. Manufacturer: AGFA, Corp, Mortsel, Belgium. Firm initiated recall is ongoing.

PRODUCT: ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa’s computed radiography product line, Recall # Z-0352-06

REASON: Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.

MANUFACTURER: Recalling Firm: AGFA Corp, Greenville, SC, by letter on/about December 1, 2005. Manufacturer: AGFA, Corp, Mortsel, Belgium. Firm initiated recall is ongoing.

PRODUCT: CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x), Recall # Z-0353-06

REASON: Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.

MANUFACTURER: Respironics California, Inc., Carlsbad, CA, by telephone on November 18, 2005 and by fax, email, or letter on November 21, 2005. Firm initiated recall is ongoing.

PRODUCT: The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PL V Continuum is capable of providing the following types of ventilatory support: Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece). . Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CP AP) modes of ventilation. . Volume-Controlled (VC). Available in AlC and SIMV. . Pressure-Controlled (PC). Available in AlC and SIMV. . Pressure Support (PS). Available in SIMV and SPONT, Recall # Z-0354-06

REASON: During product testing of the PLY Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letters on January 8, 2003. Firm initiated recall is complete.

PRODUCT: Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optional Retractable Beam Shield, Recall # Z-0355-06

REASON: Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas.

MANUFACTURER: Sandhill Scientific, Inc., Highlands Ranch, CO, by letter on December 13, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Schuster Anorectal Manometry Probe. Labeling applied to the balloon pouch reads in part: "SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe P/N: A86-4050. *** Size: Adult ... CAUTION: Balloons are made of latex rubber. *** Do not use if latex sensitivity exists.” Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free***, Product model # A86-4050, Recall # Z-0356-06 b) Schuster Anorectal Manometry Probe. Labeling applied to the balloon pouch reads in part: "SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe P/N: A86-5050. *** Size: Pediatric... CAUTION: Balloons are made of latex rubber. *** Do not use if latex sensitivity exists." Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Product model # A86-5050, Recall # Z-0357-06

REASON: The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- free symbol.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co, Bothell, WA, by letter on December 9, 2005. Manufacturer: Philips Medical Systems Ned Bv, Best, Netherlands. Firm initiated recall is ongoing.

PRODUCT: Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging. Recall # Z-0358-06

REASON: The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient's image record.

MANUFACTURER: Sandhill Scientific, Inc., Highlands Ranch, CO, by letter on December 3, 2005 and December 14, 2005. Firm initiated recall is ongoing.

PRODUCT: Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number. Recall # Z-0359-06

REASON: Labeling does not indicate that the product contains latex.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated December 9, 2005. Manufacturer: Roche Diagnostics GmbH, Graz, Austria. Firm initiated recall is ongoing.

PRODUCT: a) Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001, Recall # Z-0361-06; b) Roche brand Omni S4 Blood Gas Analyzer; Catalog # 03337138001, Recall # Z-0362-06; c) Roche brand Omni S6 Blood Gas Analyzer; Catalog # 03337154001, Recall # Z-0363-06

REASON: Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb or HHb.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letters by January 6, 2006. Manufacturer: Impac Medical Systems, Inc., Mountain View, CA. Firm initiated recall is complete.

PRODUCT: LANTIS software with MedOnc Module; MedOnc module is an option of the LANTIS radiotherapy treatment planning software distributed as a component of the firm’s linear accelerator used to deliver radiation therapy to cancer patients. The MedOnc module is distributed by Siemens Medical Solutions USA - Oncology Division, with their linear accelerators software package called LANTIS. The MedOnc module option is distributed with all LANTIS software copies, but the module must be turned on by an electronic key that is purchased by individual hospitals. Siemens Medical Solutions USA purchases the LANTIS software (code) from IMPAC Medical Systems, Inc., (REG#2950347, FEI: 1000123805). IMPAC distributes the same software under the name SEQUENCER. Recall # Z-0364-06

REASON: When using the Creatine Clearance dose calculations a software bug will allow the algorithm to assume a patients age to be in years when it is entered in months. This miscalculation may result in patients less than two years old to be seriously overdosed with radiation.

CLASS III

MANUFACTURER: Smiths Medical ASD, Inc., Gary, IN, by letter dated April 19, 2005. Firm initiated recall is complete.

PRODUCT: Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70, Recall # Z-0338-06

REASON: The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 11, 2006:

CLASS II

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated August 3, 2005 and December 15, 2005. Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing.

PRODUCT: a) Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx sterile, nonpyrogenic fluid pathway, 5.7", 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter, Recall # Z-1424-05; b) Baxter Minivolume Extension Set, 72", product code 2C5687; An Rx sterile, nonpyrogenic fluid pathway, 72", 1.6 mL Vol., with a male Luer Lock adapter; Recall # Z-1425-05; c) Baxter Minivolume Extension Set, 36”, product code 2C5685; An Rx sterile, nonpyrogenic fluid pathway, 36”, 0.9 mL Vol., with a male Luer Lock adapter, Recall # Z-1426-05; d) Baxter Mini-Infuser Microbore Extension Set, product code 2C9201; An Rx sterile, nonpyrogenic fluid pathway, 61”, 0.5 mL Vol., with Luer Lock adapters, Recall # Z-1427-05; e) Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 60", product code 2C9205; An Rx sterile, nonpyrogenic fluid pathway, 60", 1.2 mL Vol., with Luer Lock adapters, Recall # Z-1428-05; f) Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 96", product code 2C9206; An Rx sterile, nonpyrogenic fluid pathway, 96", 1.6 mL Vol., with Luer Lock adapters, Recall # Z-1429-05; g) Baxter Tamper Resistant Anti-Siphon Combination Set, 101”, product code 2L3507; An Rx sterile, nonpyrogenic fluid pathway, 101”, 2.5 mL Vol., with male Luer Lock adapter, Recall # Z-1430-05; h) Baxter Extension Set, product code 2C9219; An Rx sterile, nonpyrogenic fluid pathway, 61", 1.4 mL Vol., with Luer Lock adapters, Recall # Z-1431-05; i) Baxter Interlink System Huber Needle Extension Set, product code 2N3703; An Rx sterile, nonpyrogenic fluid pathway with Needle Gauge 22, Needle Length ¾”, Total Volume 0.40 mL, Total Length 9", Recall # 1432-05; j) Baxter Interlink System Huber Needle Extension Set, product code 2N3706; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 3/4", Total Volume 0.75 mL, Total Length 10", Recall # Z-1433-05; k) Baxter Interlink System Huber Needle Extension Set, product code 2N3707; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length ¾”, Total Volume 0.75 mL, Total Length 10", Recall # Z-1434-05; l) Baxter Interlink System Huber Needle Extension Set, product code 2N3709; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length ¾”, Total Volume 0.75 mL, Total Length 10", Recall # Z-1435-05; m) Baxter Interlink System Huber Needle Extension Set, product code 2N3710; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 1", Total Volume 0.75 mL, Total Length 10", Recall # Z-1436-05; n) Baxter Interlink System Huber Needle Extension Set, product code 2N3712; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 1", Total Volume 0.75 mL, Total Length 10", Recall # Z-1437-05; o) Baxter Interlink System Huber Needle Extension Set, product code 2N3714; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length 1”, Total Volume 0.70 mL, Total Length 10", Recall # Z-1438-05; p) Baxter Interlink System Huber Needle Extension Set, product code 2N3716; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 1-1/2”, Total Volume 0.75 mL, Total Length 10", Recall # Z-1439-05

REASON: The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.

MANUFACTURER: Recalling Firm: Encore Medical, Lp, Austin, TX, by letter on October 21, 2005. Manufacturer: Gauthier Biomedical Inc, Grafton, WI. Firm initiated recall is ongoing.

PRODUCT: Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G, Recall # Z-0328-06

REASON: Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.

MANUFACTURER: Encore Medical, Lp, Austin, TX, by letter on November 3, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement, Recall # Z-0331-06; b) Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement, Recall # Z-0332-06

REASON: The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by Customer Service Engineer visit beginning on December 1, 2005. Manufacturer: Siemens Medical Solutions, Forchheim, Germany. Firm initiated recall is ongoing.

PRODUCT: 3D TOP Ceiling Stand. X-Ray System model number 8773673, Recall # Z-0335-06

REASON: Screws on the rollers may become loose.

CLASS III

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated November 10, 2005. Firm initiated recall is ongoing.

PRODUCT: Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585, Recall # Z-0329-06

REASON: The bit may bend or fracture during use.

MANUFACTURER: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter dated December 1, 2005. Firm initiated recall is ongoing.

PRODUCT: Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482, Recall # Z-0330-06

REASON: Screwdriver handle breakage.

MANUFACTURER: Recalling Firm: Fresenius Medical Care North America, Lexington, MA, by letter dated November 28, 2005. Manufacturer: Fresenius Medical Care North America, Ogden, UT. Firm initiated recall is ongoing.

PRODUCT: a) Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N, Recall # Z-0333-06; b) Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N, Recall # Z-0334-06

REASON: Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR

MANUFACTURER: Inamed Corp, Goleta, CA, by telephone and letters on December 14, 2005. Firm initiated recall is ongoing.

PRODUCT: a) McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number: 468-380, Recall # Z-0336-06; b) McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number: 163-360, Recall # Z-0337-06

REASON: Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 4, 2006:

CLASS II

MANUFACTURER: Animas Corporation, West Chester, PA, by telephone on October 31, 2005. Firm initiated recall is complete.

PRODUCT: a) Insulin Pump, Model R1000, Recall # Z-0306-06; b) Insulin Pump, Model IR1000, Recall # Z-0307-06; c) Insulin Pump, Model IR1200, Recall # Z-0308-06; d) Insulin Pump, Model IR1250, Recall # Z-0309-06

REASON: Pumps were refurbished more than one time for the same failure mode in violation of the company’s procedure.

MANUFACTURER: Dakocytomation California, Inc., Carpinteria, CA, by letter dated October 14, 2005. Firm initiated recall is ongoing.

PRODUCT:a) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4000, Recall # Z-0310-06; b) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4001, Recall # Z-0311-06; c) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4002, Recall # Z-0312-06; d) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4003, Recall # Z-0313-06; e) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4005, Recall # Z-0314-06; f) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4006, Recall # Z-0315-06; g) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4007, Recall # Z-0316-06; h) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4008, Recall # Z-0317-06; i) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4009, Recall # Z-0318-06; j) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4010, Recall # Z-0319-06; k) EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4011, Recall # Z-0320-06

REASON: This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.

MANUFACTURER: Recalling Firm: WNCK, Inc, The Woodlands, TX, by letter on November 29, 2005. Manufacturer: James Alexander Corporation, Blairstown, NJ. Firm initiated recall is ongoing.

PRODUCT: 0.10% BreathScan Alcohol Detector. Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box, Recall # Z-0323-06

REASON: Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff.

MANUFACTURER: Recalling Firm: Toshiba American Med Sys, Inc., Tustin, CA, by letter on November 10, 2005. Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. Firm initiated recall is ongoing.

PRODUCT: a) Digital Radiography System Model DFP8000D, Recall # Z-0324-06; b) Digital Radiography System, Model DFP-8000D/FPD, Recall # Z-0325-06

REASON: To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost.

MANUFACTURER: Recalling Firm: Tecan US, Inc, Research Triangle Park, NC, by letter on/about November 8, 2005. Manufacturer: Eppendorf Ag, Hamburg, Germany. Firm initiated recall is ongoing.

PRODUCT: Disposable Tips 1000 µl with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1, Part Number 10612523, Blister 1 x 96 pcs. Recall # Z-0326-06

REASON: Double filtering of 1000 µl tips. The defect could result in cross contamination of other samples due to possible dripping of sample while moving over other samples.

CLASS III

MANUFACTURER: Recalling Firm: Philips Medical Systems, Andover, MA, by letter on November 30, 2005. Manufacturer: Katecho Inc., Des Moines, IA. Firm initiated recall is ongoing.

PRODUCT: HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads, Model M3717A, Recall # Z-0321-06

REASON: The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector.

MANUFACTURER: Recalling Firm: Olympus America, Inc, Irving, TX, by letter on November 18, 2005. Manufacturer: Olympus Diagnostica Lab-Automation Gmbh, Freiburg, Germany. Firm initiated recall is ongoing.

PRODUCT: OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter), Recall # Z-0322-06

REASON: Lab Automation System may dilute samples with water.

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