FDA Device recall Z-1197-2022
3.2MM Pellet Insertion Tray Catalog Number: B7345R1
- FDA Device
- Class II
- terminated
- Published 2022-06-08
On 2022-06-08 the FDA classified a Class II recall of 3.2MM Pellet Insertion Tray Catalog Number: B7345R1 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-1197-2022 |
| 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
3.2MM Pellet Insertion Tray Catalog Number: B7345R1
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: 2031074 2031227 2130194 2130535 2130783 UDI: 00849233016996 |
|---|
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-1197-2022%22
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