Recall Z-1037-2023 ยท FRG Wrap, Sterilization
Turbett Surgical, Inc.
Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
| Date | Jan 30, 2023 (initiated Dec 5, 2022) |
| Status | Open, Classified |
| Reason | Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries. |
| Root cause | Device Design |
| Action | ***UPDATE*** Turbett Surgical issued via E-mails Product Alert directly to the Hospital departments utilizing the device on 12-27-2022. Letter states reason for recall, health risk and action to take: Actions to be taken by the Customer/User: 1. Immediately discontinue the use of the specific devices exhibiting one or more failure(s) listed below. " Missing side supports " Broken or cracked side tab support " Backwall weld separation " Side weld separation " Crack in the backwall seam 2. Email (quality@turbettsurgical.com) with the following information. " Hospital name " Serial number |
| Quantity | 61 units |
| Distribution | US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153025 | Turbett Surgical Container Turbett Surgical, LLC, Jan 14, 2016 |