ConvaTec Recalls Non-Rebreather Masks Due to Potential Valve Defect
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Masks due to a potential defect in the check valve. The recall covers units distributed in the US and internationally.
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 corresponds to a 'High' severity score (3) in the absence of reported hospitalizations or injuries, as the hazard is theoretical or results in temporary/reversible harm.
Plain-English summary
ConvaTec, Inc. has initiated a voluntary recall of Non-Rebreather Masks, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM. The recall affects Lot Numbers 100919 and 101880. The agency classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The source text does not specify the exact nature of the defect or the reason for the recall, nor does it report any specific illnesses or injuries associated with the product. The recall was initiated by the firm on May 10, 2017, and was terminated on August 27, 2021.
Affected products were distributed in the United States (including California, Connecticut, Florida, Georgia, Illinois, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Virginia, 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. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices if found.
The recalled product
- Product
- Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM
- Manufacturer
- ConvaTec, Inc
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 (2)
- Lot Number 100919
- 101880
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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