Turbett Surgical Container, TS1500
- Company
- Turbett Surgical, Inc.
- Recall Initiated
- April 14, 2022
- Posted
- August 4, 2022
- Terminated
- February 20, 2025
- Recall Number
- Z-1501-2022
- Quantity
- 7 units
- Firm Location
- Victor, NY
Reason for Recall
Devices were subject to unapproved rework processes.
Distribution
US Nationwide Nationwide: CO, FL, NC and PA.
Lot / Code Info
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.
Root 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.