Z-1163-2022 Class II Terminated
FDA device recall Z-1163-2022 was initiated by Busse Hospital Disposables, Inc. on Feb 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… The recall status is terminated (terminated Apr 17, 2024). Affected quantity: 60 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 8, 2022
- Initiation Date
- Feb 22, 2022
- Termination Date
- Apr 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
MBB Tray Catalog Number: 9882
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: Lot 2130220 2130445 2131063 UDI: 00849233000179
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1163-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026