Recall Z-1038-2023
Turbett Surgical, Inc. · initiated December 5, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
Codes / lots: GTIN: 00859464007212 Lot Number: All Lot Numbers Serial Number: All Serial Numbers
Reason for recall
Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
FDA-determined cause: Device Design
Action taken
***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(s) " Type of failure that your container exhibited 3. Turbett Surgical will contact you to organize pick up of the damaged unit and shipment of a replacement unit. If your container does not exhibit any of these failures, please continue to monitor and inspect the condition of the container and follow the Instructions For Use (IFU) as you continue utilizing your container. 4. If your container does not exhibit any of these failures, please email quality@turbettsurgical.com stating that your container(s) do not exhibit any of these failures. Please continue to monitor and inspect your devices prior to assembling for sterilization AS WELL AS after sterilization and cooling to ensure expected outcomes. Reminder to follow the Instructions For Use (IFU) as you continue utilizing your TS-1200 container. If you have any questions about the content of this letter, please contact Mark Petras at quality@turbettsurgical.com. ________________________________________________________________________ Turbett Surgical issued Emails to the Hospital department on 12/7/2022. Sales representatives were notified on 12/5/22 to switch out the other container. Letter states reason for recall, health risk and action to take: 1. Immediately verify that the specific serial numbered devices listed below, continues to operate without creating wet loads or the sterilization process is not compromised.
Details
- Recall number
- Z-1038-2023
- Initiated
- December 5, 2022
- Posted by FDA
- January 30, 2023
- Product code
- FRG – Wrap, Sterilization
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.
- Recalling firm
- Turbett Surgical, Inc., Victor, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1037-2023 Class II | Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that…Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments… | 12/05/2022Open, Classified |