Device recall
Z-1569-2021: REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the…
FDA device recall · Class II · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1569-2021 |
|---|---|
| Recall event | 87703 |
| Product | REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein). |
| Product code | FPA |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K082806 |
| 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