Device recall
Z-1477-2021: Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number…
FDA device recall · Class II · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-1477-2021 |
|---|---|
| Recall event | 87647 |
| Product | Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow. |
| Product code | DRS |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 20, 2023 |
| 510(k) numbers | K961404 |
| FEI number | 3012307300 |
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