Device recall
Z-0805-2019: icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System…
FDA device recall · Class I · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0805-2019 |
|---|---|
| Recall event | 81942 |
| Product | icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. |
| Product code | ONB |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 29, 2024 |
| 510(k) numbers | K131549 |
| FEI number | 2025816 |
At a glance
- 1–9 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