Recall Z-1501-2022
Turbett Surgical, Inc. · initiated April 14, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Turbett Surgical Container, TS1500
Codes / lots: UDI-DI (GTIN): 00859464007113; Lot No./Serial No.: 100036/2017061015, 100036/2017061016, 100036/2017061017, 100036/2017061019, 100036/2017061023, 100036/2017061025, 100065/2017121001 and 100081/2018031004.
Reason for recall
Devices were subject to unapproved rework processes.
FDA-determined cause: Process control
Action taken
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 Response Form to Quality@Turbettsurgical.com. Turbett will contact customers to coordinate the replacement of the unit and correction of the recalled device. Customers with any questions can call 585-755-0133x106 from Monday through Friday, from 8:00 AM to 4:30 PM.
Details
- Recall number
- Z-1501-2022
- Initiated
- April 14, 2022
- Posted by FDA
- August 4, 2022
- Terminated
- February 20, 2025
- Product code
- FRG – Wrap, Sterilization
- Quantity
- 7 units
- Distribution
- US Nationwide Nationwide: CO, FL, NC and PA.
- Recalling firm
- Turbett Surgical, Inc., Victor, NY