Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

U.S. FDA — Device Enforcement · United States · 2020-11-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0743-2021
Date of alert
2020-11-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Westmed, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00709078005718
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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