Class 2 Device Recall Sleek OTWREF 4261201XInflated Balloon

• Date Initiated by Firm: January 31, 2011
• Date Posted: September 21, 2012
• Recall Status: Terminated on November 26, 2013
• Recall Number: Z-2441-2012
• Recall Event ID: 62927
• PMA Number: P880003
• Product Classification: Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
• Product: 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.
• Code Information: Lot #50027149
• Recalling Firm/ Manufacturer: Cordis Corporation; 14201 Nw 60th Ave; Miami Lakes FL 33014-2802
• For Additional Information Contact: Hal Baden; 786-313-2365
• Manufacturer 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.
• FDA Determined Cause: Error in labeling
• Action: Cordis (Johnson & Johnson Company) sent an Urgent Medical Device Field Corrective Action Notice dated January 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review, sign, and return the enclosed Acknowledgment Form directly to Cordis at the fax number on the form, or to their local sales representative. Pass the revised labeling notice to all who need to be aware within their facility or organization. Also, customers were asked to maintain awareness of this notice until all affected product in their facility has been consumed. In addition to their local Cordis representative, they may contact the normal HCS Customer Service number at 1-800-327-7714, option 1, option 3. For questions regarding this recall call 786-313-2365.
• Quantity in Commerce: 5 units
• Distribution: Worldwide Distribution - USA and Germany
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LOX