Device product
SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
Z-1184-2022
Product summary
- Event
- Event 90072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 units
- Official record key
device-enforcement:Z-1184-2022
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: 2110102 2110090 2110268 UDI: 00849233004641
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