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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012
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Event Detail

Event ID 62927
Product Type Devices
Status Completed
Recalling Firm Cordis Corporation
City Miami Lakes
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-01-31
Initial Firm Notification of
Consignee or Public		 E-Mail
Distribution Pattern Worldwide Distribution - USA and Germany

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by 2013-09***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***Tel: +353--(0)62-70000. The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter. Lot #50027149 Class II On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled. 5 units Z-2441-2012
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***Clearstream Technologies, Ltd.***Moyne Upper, Enniscorthy Co Wexford, Ireland***Phone: +353-53-92-37111***Fax: +353-53-92-37-100***Made in Ireland***Distributed by: Cordis Cashel***Cahir Road, Cashel, Co. Tipperary, Ireland***". The SLEEK OTW Percutaneous Transluminal Angioplasty (PTA) Peripheral Catheter Family is a non-reusable semi-compliant coaxial design catheter with a balloon mounted on its distal tip. The hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port, used to inflate the balloon. The catheter shaft is small beneath the balloon achieve low profile. The distal tip is further tapered to accept the appropriate guidewire. Platinum iridium bands serve to locate the balloon under fluoroscopy. A 0.014" (0.356 mm) guidewire is recommended for use with the SLEEK OTW Catheter. Lot #50026688. Class II On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Product is incorrectly labeled. 1 unit Z-2442-2012
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