Device recall
Z-0939-2021: FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm…
FDA device recall · Class II · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-0939-2021 |
|---|---|
| Recall event | 87013 |
| Product | FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use. |
| Product code | MVR |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K191252 |
| FEI number | 1417572 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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