Device recall
Z-2816-2026: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath…
FDA device recall · Class II · Windstone Medical Packaging, Inc.
Key facts
| Recall number (Z-number) | Z-2816-2026 |
|---|---|
| Recall event | 99347 |
| Product | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B |
| Product code | OES |
| 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
- 10–99 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