Device recall
Z-2464-2025: AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART…
FDA device recall · Class II · American Contract Systems Inc
Key facts
| Recall number (Z-number) | Z-2464-2025 |
|---|---|
| Recall event | 97358 |
| Product | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P; 5)… |
| Product code | OEZ |
| Recalling firm | American Contract Systems Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3008492337 |
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