Device product
Nerve Block Tray Catalog Number: 8415
Z-1158-2022
Product summary
- Event
- Event 90072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 420 units
- Official record key
device-enforcement:Z-1158-2022
Official wording
Reason: Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products
Code information: Lot Numbers: 2030832 2031190 2130252 2130629 2130742 2131125 2131223 UDI: 00849233016811
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products