Device recall
Z-0818-2024: Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V…
FDA device recall · Class II · American Contract Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0818-2024 |
|---|---|
| Recall event | 93656 |
| Product | Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number AGOH98Q; f) OPEN HEART… |
| Product code | OEZ |
| 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