Recall Z-0165-2013 ยท LDF Electrode, Pacemaker, Temporary
Oscor, Inc.
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
| Date | Oct 29, 2012 (initiated Jul 25, 2012) |
| Status | Terminated |
| Reason | Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification. |
| Root cause | Process control |
| Action | Oscor sent a customer notification letter dated July 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to send the listed models and lots in their inventory back to the recalling firm for immediate replacement. They were also instructed to call Oscor Customer Service at 727-937-2511 to obtain a Return Goods Product (RGA) number. For questions regarding this recall call 727-937-2511, ext. 133. |
| Quantity | 1425 |
| Distribution | Worldwide Distribution - USA including OR, FL, Al, TX, NM, CA, AL, PA, KY, IN, OH, and IL and internationally to Canada, Russia, and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831695 | TEMP. CARDIAC PACING WIRE TME 60/61/65 Oscor, Inc., Oct 20, 1983 |