Device recall
Z-1098-2019: SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV…
FDA device recall · Class I · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1098-2019 |
|---|---|
| Recall event | 82291 |
| Product | SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the… |
| 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