ConvaTec Recalls Non-Rebreather Oxygen Masks Due to Quality Concerns
ConvaTec is voluntarily recalling specific lots of adult non-rebreather oxygen masks. The recall was initiated due to quality concerns, with no specific injuries reported in the source text.
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 indicates a reasonable probability of temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.
Plain-English summary
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing. The recall was initiated by the firm on May 10, 2017, and was classified as Class II by the FDA. The affected product codes include 3108-E, 3108MM, 86-106E, 86-108-E, LM-86-106, PMD06002, and PMD06003.
The source text does not specify the exact reason for the recall or report any illnesses or injuries associated with the use of these devices. The recall status is currently terminated, having been closed on August 27, 2021.
The affected products were distributed in multiple U.S. states, including California, Connecticut, Florida, Georgia, Illinois, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, and Virginia, as well as Puerto Rico. The products were also distributed internationally in countries such as Australia, Belgium, Canada, and the United Kingdom. Consumers should check their product lot numbers against the list provided by the FDA to determine if their specific unit is affected.
The recalled product
- Product
- Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
- 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 (Product Code 3108-E) 100132
- 104079
- 105936
- (Product Code 3108MM) 103715
- (Product Code 86-106E) 100056
- 101452
- 101725
- 102695
- 103006
- 104041
- 104198
- 104634
- 104969
- 105687
- (Product Code 86-108E) 100057
- 100200
- 101453
- 101726
- 102080
- 102477
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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