Z-1157-2022 Class II Terminated
FDA device recall Z-1157-2022 was initiated by Busse Hospital Disposables, Inc. on February 22, 2022 and is designated Class II. Reason for recall: 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 adequ… The recall status is terminated (terminated April 17, 2024). Affected quantity: 4218 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 8, 2022
- Initiation Date
- February 22, 2022
- Termination Date
- April 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4218 units
Product Description
I.V. Start Kit Catalog 8172
Reason for Recall
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
Distribution Pattern
Nationwide
Code Information
Lot Numbers: 2020561 2020560 2020650 2120089 2120018 2120344 2120442 2120645 2120768 2120911 UDI: 00849233015883