ConvaTec Recalls Non-Rebreathing Masks and Reservoir Bags Due to Valve Defect
ConvaTec, Inc. is voluntarily recalling specific lots of non-rebreathing masks and reservoir bags because the check valves may fail to function correctly.
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) when no hospitalizations or serious injuries are explicitly reported in the source text.
Plain-English summary
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreathing Masks, Reservoir Bags, Check Valves, One Side Valves, and Tubing. The affected products include Product Codes 106-E, 3226MM, and 9108MM. The recall was initiated on May 10, 2017, and was classified as Class II by the FDA.
The recall is due to a defect where the check valves may not function as intended. This malfunction could potentially allow the user to inhale exhaled air, which may result in the delivery of incorrect oxygen concentrations. The FDA classifies this as a Class II recall, indicating that the use of the product could cause temporary or medically reversible health consequences.
The 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, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam. Specific lot numbers are listed in the source data for each product code.
Healthcare providers and consumers should stop using the affected products immediately. ConvaTec, Inc. is the recalling firm and will provide further instructions regarding the return or replacement of the devices. The recall status is currently terminated as of August 27, 2021.
The recalled product
- Product
- Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM
- 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 (20)
- Lot Number (Product Code 106-E)
- 100152
- 102095
- 102154
- 103122
- 103159
- 103385
- 103527
- 103558
- 104009
- 104321
- 104322
- 104328
- 104701
- 104975
- 105569
- 105656
- 1045675
- (Product Code 3226MM) 100720
- 101141
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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