Device recall
Z-0346-2026: ICU Medical ChemoLock Closed Vial Spike REF: CL-80
FDA device recall · Class II · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0346-2026 |
|---|---|
| Recall event | 97583 |
| Product | ICU Medical ChemoLock Closed Vial Spike REF: CL-80 |
| Product code | ONB |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K131549 |
| FEI number | 2025816 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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