ConvaTec Recalls Infant High Concentration Non-Rebreather Oxygen Masks
ConvaTec is recalling specific lots of infant high concentration non-rebreather oxygen masks due to a Class II safety concern.
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 is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause 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 Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E. The recall was initiated by the firm on May 10, 2017, and is classified as Class II by the U.S. Food and Drug Administration.
The affected product was 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 15 specific lot numbers: 100071, 100242, 100253, 100601, 100749, 100811, 101143, 101480, 102711, 103195, 103275, 103324, 105511, 105571, and 105660.
The source text does not specify the exact reason for the recall or the quantity of units affected. The recall status is listed as Terminated as of August 27, 2021. Consumers should check their product lot numbers against the list provided and contact ConvaTec for further instructions.
The recalled product
- Product
- Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-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 (15)
- Lot Number 100071
- 100242
- 100253
- 100601
- 100749
- 100811
- 101143
- 101480
- 102711
- 103195
- 103275
- 103324
- 105511
- 105571
- 105660
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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