Z-1183-2022 Class II Terminated
FDA device recall Z-1183-2022 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: 30 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
- 30 units
Product Description
SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
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: 2010304 UDI: 00849233004641