Device recall
Z-0964-2019: Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as…
FDA device recall · Class II · American Contract Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0964-2019 |
|---|---|
| Recall event | 81710 |
| Product | Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK BASIC VIII CFH - 2073903, Tray Number… |
| Product code | FYA |
| Recalling firm | American Contract Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 10, 2021 |
| FEI number | 3008908305 |
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