Device recall
Z-2800-2018: DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear…
FDA device recall · Class II · ICU Medical de Mexico, S.A. de C.V.
Key facts
| Recall number (Z-number) | Z-2800-2018 |
|---|---|
| Recall event | 80460 |
| Product | DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifold, Check Valve, Rotating Luer, Filter Cap is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to… |
| Product code | FMG |
| Recalling firm | ICU Medical de Mexico, S.A. de C.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2024 |
| 510(k) numbers | K964435 |
| FEI number | 3003807466 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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