Device product
I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
Z-1147-2022
Product summary
- Event
- Event 90072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2475
- Official record key
device-enforcement:Z-1147-2022
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: 2020514 2020525 2020734 2120255 2120304 2120325 2120439 UDI: 00849233010017
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