Device recall
Z-2169-2020: Sterile Custom Packs to be used in surgical procedures.
FDA device recall · Class II · American Contract Systems
Key facts
| Recall number (Z-number) | Z-2169-2020 |
|---|---|
| Recall event | 85502 |
| Product | Sterile Custom Packs to be used in surgical procedures. |
| Product code | FTN |
| Recalling firm | American Contract Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 25, 2020 |
| FEI number | 3011389083 |
At a glance
- None Linked 510(k)s
- 10–99 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