ConvaTec Recalls Adult High Concentration Non-Rebreather Oxygen Masks
ConvaTec, Inc. is voluntarily recalling specific lots of Adult High Concentration Non-Rebreather Oxygen Masks due to a Class II defect.
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 situation where use of, or exposure to, a violative product may cause 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 Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM. The affected lot numbers are 100721, 100733, 104106, 104798, and 109824. The recall was initiated on May 10, 2017, and is classified as Class II by the FDA.
The source text does not specify the exact reason for the recall or the specific defect associated with these oxygen masks. The products were distributed to various locations 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. The products were also distributed internationally to 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 facilities should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The recall status is currently terminated.
The recalled product
- Product
- Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Oxygen Therapy
- 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 (5)
- Lot Number 100721
- 100733
- 104106
- 104798
- 109824
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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