FDAFDA · Food and drugs·Recall number Z-0165-2013
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
Published November 7, 2012 · Recall initiated: July 25, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Oscor, Inc.
- Distributor
- 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
- Lot
- Model Number TME60S, Lot #C1-07101 Model Number TME64S, Lot #C1-07056 Model Number TME64S, Lot #C1-07057 Model Number TME64S, Lot #C1-07058 Model Number TME64S, Lot #C1-07111 Model Number TME64S, Lot #C1-07112 Model Number TME64S, Lot #C1-07113 Model Number TME64S, Lot #C1-07114 Model Number TME64S, Lot #C1-07122 Model Number TME64S, Lot #C1-07123 Model Number TME64S, Lot #C1-07124 Model Number TME64S, Lot #C1-07125 Model Number TME64C, Lot #C1-07143 Model Number TME64S, Lot #C1-07151 Model Number TME64S-3, Lot #C1-07156 Model Number TME65S, Lot #C1-07174
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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