Z-1168-2022 Class II Terminated
FDA device recall Z-1168-2022 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: 40 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
- 40 units
Product Description
Cervical Tray Catalog Number: 3765R2
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: 2031213S 2130221S UDI: 00849233015203
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1168-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026