FDA Device recall Z-1178-2022
Procedural Accessory Kit Catalog Number: 9665R2
- FDA Device
- Class II
- terminated
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of Procedural Accessory Kit Catalog Number: 9665R2 by Busse Hospital Disposables, citing 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 unc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1178-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-22 |
| Published | 2022-06-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Busse Hospital Disposables |
| Distribution | US |
Product
Procedural Accessory Kit Catalog Number: 9665R2
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
Identifiers
| code_info | Lot Numbers: 2031038 UDI: 00860000210461 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1178-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.