The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0744-2021·Announced 2021-01-06

Westmed Adult CO2/O2 Mask Recall Due to Loose Tube Fitment

Westmed is recalling 1,200 units of Adult CO2/O2 Masks because the oxygen delivery tube may become loose, potentially delaying treatment.

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 loose connection could delay treatment, but no injuries or illnesses have been reported.

Plain-English summary

Westmed, Inc. is recalling 1,200 units of REF 0562F Adult CO2/O2 Masks. The recall involves a specific lot (091720N71) distributed outside the US, with broader distribution reported across the US and in Canada, Korea, and the United Kingdom.

The recall is issued because 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, which may lead to a possible delay in treatment.

The affected product is intended to connect with an oxygen source to deliver oxygen therapy to the patient. Consumers and healthcare providers should check their inventory for the specific lot number and product description listed in the recall notice.

The recalled product

Product
REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - 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
1,200

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 # 091720N71 (Distributed outside US)

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 →

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