Recall Z-1153-2022 ยท OGJ Nerve Block Tray
Busse Hospital Disposables, Inc.
Epidural Tray Catalog 1307
| Date | Feb 22, 2022 |
| Status | Terminated |
| 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 |
| Root cause | Other |
| Action | Busse Hospital Disposables issued Product Recall Notification on 2/22/22 Re: PDI Prevantics Swab, Swabstick, and Maxi Swabstick Voluntary Recall stating reason for recall , health risk and action to take: Busse Hospital Disposables has initiated a voluntary recall on any products containing the affected product. However, it is important to note the integrity of the kit and other components is not compromised by the recalled PDI prevantic pouches. PDI shipped this product between February 2020 and July 2021. Please take the following actions: 1. Immediately check your inventory for the lots |
| Quantity | 64 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.