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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