FDA Device recall Z-0743-2021
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 O…
- FDA Device
- Class II
- terminated
- Published 2021-01-06
On 2021-01-06 the FDA classified a Class II recall of 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 O… by Westmed, citing there is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0743-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-11 |
| Published | 2021-01-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Westmed |
| Distribution | US |
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.
Reason
There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection to the mask adapter resulting in a possible delay in treatment.
Identifiers
| code_info | Lot # 091620N04 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0743-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.