The Recall Desk
HighFDA (Devices)·Z-2228-2017·Announced 2017-06-14

ConvaTec Recalls Elongated Oxygen Masks Due to Tubing Detachment Risk

ConvaTec is recalling elongated oxygen masks because tubing may detach from the connector, potentially disrupting oxygen supply to users.

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 can disrupt oxygen supply, posing a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

ConvaTec, Inc. is recalling 816,709 units of Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E. The recall involves specific lot numbers including 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, and 112530. These products were distributed in multiple U.S. states and internationally, including Canada, Australia, and various European and Asian countries.

The recall was initiated due to reports from different end users that the oxygen tubing detached from the mask connector either prior to use or during use. The defect is caused by an improper solvent bond between the tubing and the connector. While the issue affects less than 2% of the recalled product, it poses a potential risk of harm by disrupting the oxygen supply to the user.

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

The recalled product

Product
Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Manufacturer
ConvaTec, Inc
Category
Medical Device — Oxygen Therapy Equipment
Hazard
Affected units
816,709

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 (17)

  • Lot Number 102153
  • 102339
  • 102941
  • 103176
  • 103453
  • 103718
  • 103919
  • 104471
  • 105034
  • 105282
  • 105427
  • 105567
  • 105996
  • 106960
  • 108658
  • 112024
  • 112530

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 18 recalled by ConvaTec, 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 18 products in this recall →

Related recalls

Same manufacturer · ConvaTec, Inc

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Same hazard · tubing detachment

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