Reported Nov 7, 2012 · Terminated
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery…
Oscor, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Oscor, Inc. · 3816 Desoto Boulevard · Palm Harbor, FL · 34683-1618
Is this the product you have?
- Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
- Lot codes and dates
32 of 32 products
Products covered by this recall Model / number Product as published TME60S— — Lot #C1-07101 TME64S— — Lot #C1-07056 TME64S— — Lot #C1-07057 TME64S— — Lot #C1-07058 TME64S— — Lot #C1-07111 TME64S— — Lot #C1-07112 TME64S— — Lot #C1-07113 TME64S— — Lot #C1-07114 TME64S— — Lot #C1-07122 TME64S— — Lot #C1-07123 - Amount recalled
- 1425
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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