Device recall
Z-0743-2021: REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10'…
FDA device recall · Class II · Westmed, Inc.
Key facts
| Recall number (Z-number) | Z-0743-2021 |
|---|---|
| Recall event | 86903 |
| Product | REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. |
| Product code | KGB |
| Recalling firm | Westmed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 7, 2023 |
| 510(k) numbers | K913164 |
| FEI number | 1000374126 |
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