Drug recall
Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after…
FDA recall event 63112 · Class II · Oscor, Inc.
Key facts
| Event ID | 63112 |
|---|---|
| Recall numbers | Z-0165-2013 |
| Recalling firm | Oscor, Inc. |
| Product type | Devices |
| Products | Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 25, 2012 |
| Report date | Nov 7, 2012 |
| Termination date | Dec 17, 2013 |
| City | Palm Harbor |
| State | FL |
| Country | United States |
| FEI number | 1035166 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: