Device recall
Z-0512-2019: Medex High Pressure Stopcock used to control the direction of IV fluid flow…
FDA device recall · Class II · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-0512-2019 |
|---|---|
| Recall event | 81599 |
| Product | Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened. |
| Product code | FMG |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 5, 2020 |
| FEI number | 3012307300 |
At a glance
- None Linked 510(k)s
- 1–9 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