Device recall
Z-1359-2025: OPEN HEART A PACK, Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
FDA device recall · Class II · American Contract Systems Inc
Key facts
| Recall number (Z-number) | Z-1359-2025 |
|---|---|
| Recall event | 96343 |
| Product | OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02 |
| 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
- 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