Device recall
Z-0822-2024: Custom procedural convenience kits and trays, gastroenterological & urological…
FDA device recall · Class II · American Contract Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0822-2024 |
|---|---|
| Recall event | 93656 |
| Product | Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit number GUGE09I; e) LAP CHOLE PACK… |
| Product code | FDE |
| Recalling firm | American Contract Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3003309947 |
At a glance
- None Linked 510(k)s
- 10–99 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