Device recall
Z-2818-2026: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop…
FDA device recall · Class II · Windstone Medical Packaging, Inc.
Key facts
| Recall number (Z-number) | Z-2818-2026 |
|---|---|
| Recall event | 99347 |
| Product | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B; 4) Vein Pack - RX, Part Number AMS11398C; 5) Radiology Tray-RX, Part Number AMS1217A; 6) Custom Pack… |
| Product code | LRO |
| 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
- 1,000+ 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