ConvaTec Recalls Rebreather Oxygen Masks Due to Defect
ConvaTec is voluntarily recalling specific lots of Rebreather Oxygen Masks. The recall was initiated by the firm and is classified as Class II by the FDA.
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 that use of the product could 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 Rebreather Oxygen Masks, Adult 7' (2.1 m) Tubing. The affected product codes are 3104MM, 9104-E, and PMD06001. The recall was initiated by the firm on May 10, 2017, and was classified as Class II by the FDA on June 2, 2017.
The source text does not specify the exact reason for the recall or the specific defect involved. The recall status is currently terminated as of August 27, 2021. The affected units were distributed across numerous 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 and several international locations.
Consumers who possess these specific product codes and lot numbers should stop using the devices and contact ConvaTec, Inc. for further instructions. The recall was initiated via letter notification to initial firms.
The recalled product
- Product
- Rebreather Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001
- 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 (7)
- Lot Number (Product Code 3104MM) 103665
- (Product Coe 9104-E) 100130
- 101056
- 101638
- 102066
- 104977
- (Product Code PMD06001) 100914
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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