Recall Z-1182-2022 ยท FBQ Trocar, Gastro-Urology
Busse Hospital Disposables, Inc.
SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
| 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 | 120 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.