Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery
FDA device recall Z-0165-2013 · posted 2012-10-29 · Terminated
Recall details
- Recalling firm
- Oscor, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LDF
- Quantity affected
- 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
- Date initiated
- 2012-07-25
- Date posted
- 2012-10-29
- Date terminated
- 2013-12-17
- Location
- Palm Harbor, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TEMP. CARDIAC PACING WIRE TME 60/61/65 (K831695) | Oscor, Inc. | 1983-10-20 |