Device product
"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
Z-1180-2022
Product summary
- Event
- Event 90072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 units
- Official record key
device-enforcement:Z-1180-2022
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: 2110082 2110174 2110254 2110221 UDI: 00849233004733
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