Recall Z-1111-2022 ยท FRG Wrap, Sterilization
TURBETT SURGICAL, LLC
Turbett Surgical Container, TS1500
| Date | May 18, 2022 (initiated Apr 1, 2022) |
| Status | Open, Classified |
| Reason | Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. |
| Root cause | Device Design |
| Action | Firm notified customers on April 1, 2022 via email. Customers were instructed to immediately discontinue use of the product and quarantine the product. |
| Quantity | 232 units |
| Distribution | Domestic distribution to PA, CA, and NY only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153025 | Turbett Surgical Container Turbett Surgical, LLC, Jan 14, 2016 |