Device recall
Z-1284-2017: Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack…
FDA device recall · Class II · Windstone Medical Packaging, Inc.
Key facts
| Recall number (Z-number) | Z-1284-2017 |
|---|---|
| Recall event | 76280 |
| Product | Custom Pack, part number AMS4776 Custom Pack, part number AMS4776(A Custom Pack, part number AMS5643 Custom Pack, part number AMS5643(A Custom Pack, part number AMS6012 Custom Pack, part number AMS6383 Custom Pack, part number PSS2135(B Custom Pack, part number PSS2798(B Custom Pack, part number… |
| Product code | FSY |
| Recalling firm | Windstone Medical Packaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 3, 2017 |
| FEI number | 1000125955 |
At a glance
- None Linked 510(k)s
- 100–999 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