Device recall
Z-1389-2024: Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following…
FDA device recall · Class II · Applied Medical Resources Corp
Key facts
| Recall number (Z-number) | Z-1389-2024 |
|---|---|
| Recall event | 94034 |
| Product | Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - HPATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT, GK1033, AME STANDARD KIT… |
| Product code | MDM |
| Recalling firm | Applied Medical Resources Corp |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 2027111 |
At a glance
- None Linked 510(k)s
- 1–9 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