The Recall Desk
HighFDA (Devices)·Z-0741-2021·Announced 2021-01-06

Westmed Elongated Oxygen Mask Recalled for Loose Tube Connection

Westmed is recalling 3,000 units of the REF 3102-E Elongated Oxygen Mask because the tube connection may become loose, potentially delaying oxygen therapy.

What this means for you

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 medical device where a defect could delay treatment, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Westmed, Inc. is recalling 3,000 units of the REF 3102-E Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing. The product is intended to connect with an oxygen source to deliver oxygen therapy to patients. The recall is due to a potential issue where 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. The affected units are identified by Lot # 091120N53. The product was distributed worldwide, including nationwide in the United States and in Canada, Korea, and the United Kingdom.

Consumers and healthcare providers should stop using the affected masks and contact Westmed, Inc. for further instructions or a replacement.

The recalled product

Product
REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Manufacturer
Westmed, Inc.
Category
Medical Device — Oxygen Therapy
Hazard
Affected units
3,000

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 # 091120N53

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.

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Same hazard · loose connection

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