Device product
SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
Z-1190-2022
Product summary
- Event
- Event 90072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-1190-2022
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: 2110054 2110116 UDI: 00849233005365
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