Recall Z-0404-2016 ยท KCY Tourniquet, Pneumatic
STERILMED, INC.
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
| Date | Nov 13, 2015 |
| Status | Terminated |
| Reason | Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed cannot assure the sterility of all units in the recalled lots. The introduction of non-sterile product into a sterile operative field raises the risk of potential infection. Sterilmed has not received any reports of Adverse Events for this issue. |
| Root cause | Process control |
| Action | Consignees were sent a Sterilmed "Urgent Medical Device Recall: letter dated November 13, 2015. The letter was addressed to Materials Manager, Risk Manager and Operating Room Director. The letter described the product affected, the description of the problem and the Actions Required. Requested consignees to quarantine and return affected product and to complete and return the Business Reply Form. For questions contact Sterilmed's Customer Care Team at 888-541-0078. |
| Quantity | 174,960 |
| Distribution | US: Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.