Enforcement Report - Week of October 3, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-2441-2012 |
| Classification | Class II |
| Code Info | Lot #50027149 |
| Product Distributed Qty | 5 units |
| Reason For Recall | 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. |
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 | |
| Distribution Pattern | Worldwide Distribution - USA and Germany |
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