FDA recall Z-1501-2022
Turbett Surgical, Inc. · Class II · device
Product
Turbett Surgical Container, TS1500
Reason for recall
Devices were subject to unapproved rework processes.
Distribution
US Nationwide Nationwide: CO, FL, NC and PA.
Key facts
- Status
- Terminated
- Initiation date
- 2022-04-14
- Report date
- 2022-08-10
- Termination date
- 2025-02-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Victor, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1501-2022