Recall Z-2819-2015 ยท KCY Tourniquet, Pneumatic
STERILMED, INC.
Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.
| Date | Sep 28, 2015 (initiated Aug 24, 2015) |
| Status | Terminated |
| Reason | Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices. |
| Root cause | Labeling False and Misleading |
| Action | Sterilmed sent an "Urgent Medical Device Recall" letter dated August 24 2015. The letter was addressed to Materials Manger, Risk Manger and Operating Room Supervisor. The letter identified the affected product, problem and actions to be taken. Customers are requested to return all affected product, sign and return the enclosed Customer Response Questionnaire and the Customer Response Form per the instructions on the Forms. For questions contact Sterilmed's Customer Care Team at 888-541-0078. |
| Quantity | 43 |
| Distribution | US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.