Recall Z-1101-2022 ยท KDD Kit, Surgical Instrument, Disposable
Windstone Medical Packaging, Inc.
Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828, Ultrasound Biopsy Pack -Rx/AMS6828A, C Access Tray/AMS9954, C Access Tray/AMS9954A, Acce
| Date | Mar 21, 2022 |
| Status | Open, Classified |
| Reason | Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, 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 | Nonconforming Material/Component |
| Action | On 03/21/22, recall notices were emailed to customers who were informed that only the Prevantics swabs and/or swabsticks contained inside the kits are affected. All other components in the kits are not affected by the recall. The firm asked customers to overlabel affected kits with a label/sticker stating the reason for recall and providing instruction once the kit is opened for use; specifically the affected swab/swabsticks should be set aside, rendered unusable, and disposed of. Customers needing replacement swabs/swabsticks were asked to indicate this on the recall notice response form wh |
| Quantity | 53,412 |
| Distribution | US: PA, WA, FL, GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.