Recall Z-0564-05 ยท KCY Tourniquet, Pneumatic
Zimmer Orthopaedic Surgical Products
Zimmer Orthopaedic Surgical Products, Disposable Cuff, Dual Port, Double Bladder Cuff, Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.
| Date | Feb 25, 2005 (initiated Feb 11, 2005) |
| Status | Terminated |
| Reason | The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release. |
| Root cause | Other |
| Action | Consignees were notified by letter on 02/11/2005. |
| Quantity | Total 1460 cuffs |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.