Device recall
Z-0216-2021: 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock…
FDA device recall · Class II · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0216-2021 |
|---|---|
| Recall event | 86054 |
| Product | 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system… |
| Product code | FPA |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2023 |
| 510(k) numbers | K964435 |
| FEI number | 2025816 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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