Device recall
Z-1101-2022: Prevantics swabs and/or swabsticks contained inside the following Aligned…
FDA device recall · Class II · Windstone Medical Packaging, Inc.
Key facts
| Recall number (Z-number) | Z-1101-2022 |
|---|---|
| Recall event | 89969 |
| Product | 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… |
| Product code | KDD |
| Recalling firm | Windstone Medical Packaging, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1000125955 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database