ConvaTec Recalls Elongated Oxygen Masks Due to Defect
ConvaTec is voluntarily recalling elongated oxygen masks in the US and 27 other countries. The recall was initiated by the firm and is classified as FDA Class II.
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 is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible adverse health consequences. The source does not report specific injuries or deaths, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ConvaTec, Inc. is voluntarily recalling specific lots of Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E. The recall was initiated by the firm on May 10, 2017, and was classified as Class II by the FDA. The reason for the recall is not explicitly stated in the provided source text.
The affected products were distributed in the United States (CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA, and Puerto Rico) and internationally in Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam. The recall covers 25 specific lot numbers, including 100454, 100734, and 109186.
The recall status is currently Terminated, with a termination date of August 27, 2021. Consumers should check their product lot numbers against the list provided by the FDA or ConvaTec to determine if their device is affected.
The recalled product
- Product
- Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E
- Manufacturer
- ConvaTec, Inc
- Hazard
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 (20)
- Lot Number 100454
- 100734
- 101053
- 101121
- 101607
- 101665
- 101999
- 102352
- 102726
- 102766
- 102785
- 103179
- 103254
- 103529
- 104103
- 104457
- 104653
- 104706
- 104799
- 105213
Distribution
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.
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