The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0743-2021·Announced 2021-01-06

Westmed Adult Elongated CO2/O2 Mask Recall for Loose Fitment

Westmed is recalling 600 units of Adult Elongated CO2/O2 Masks because the tubing connection may become loose, potentially delaying oxygen therapy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where a potential delay in treatment is identified, but no injuries or illnesses have been reported.

Plain-English summary

Westmed, Inc. is recalling 600 units of REF 0930 Adult Elongated CO2/O2 Masks. The recall involves a specific lot (Lot # 091620N04) distributed worldwide, including across the United States and in Canada, Korea, and the United Kingdom.

The recall is issued because the fitment between the oxygen delivery tube and the mask adapter may become loose. This defect could result in the device tubing not making a secure connection to the mask adapter, which may lead to a possible delay in treatment for patients receiving oxygen therapy.

Consumers and healthcare providers should stop using the affected masks and contact Westmed, Inc. for instructions on how to return or replace the product.

The recalled product

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.
Manufacturer
Westmed, Inc.
Category
Medical Device — Oxygen Therapy Equipment
Hazard
Affected units
600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # 091620N04

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Westmed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Westmed, Inc.

See all →

Same hazard · loose connection

See all →

Similar recalls