Recall Z-1501-2022 ยท FRG Wrap, Sterilization
Turbett Surgical, Inc.
Turbett Surgical Container, TS1500
| Date | Aug 4, 2022 (initiated Apr 14, 2022) |
| Status | Terminated |
| Reason | Devices were subject to unapproved rework processes. |
| Root cause | Process control |
| Action | The firm distributed recall notification to hospitals via email on 04/14/2022. The recall notification identifies the reason for recall of specific TS1500 units to be that the repair process employed could restrict the customer's ability to clean and visually check the device for cleanliness. This can be identified by the customer by evidence of bioburden or particulate buildup in the seams of the device. Inadequate or incomplete cleaning of the unit may compromise the sterility of the load. The firm asks customers to immediately discontinue use of the device and complete the provided Return |
| Quantity | 7 units |
| Distribution | US Nationwide Nationwide: CO, FL, NC and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153025 | Turbett Surgical Container Turbett Surgical, LLC, Jan 14, 2016 |