Device recall
Z-1097-2019: icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b)…
FDA device recall · Class I · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1097-2019 |
|---|---|
| Recall event | 82291 |
| Product | icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system… |
| Product code | FPA |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 4, 2024 |
| FEI number | 2025816 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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