ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Defect
ConvaTec is voluntarily recalling specific lots of pediatric oxygen masks. The recall addresses a potential defect in the high-concentration rebreather devices.
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 that 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 or for high-risk pathogens without reported illness, fitting the Class II classification for medical devices.
Plain-English summary
ConvaTec, Inc. is voluntarily recalling specific lots of Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector. The affected products include Product Code 3224-E and Product Code 3226-E. The recall was initiated by the firm on May 10, 2017, and was classified as Class II by the FDA.
The distribution of these products included various U.S. states, Puerto Rico, and numerous international locations, including Australia, Canada, and countries in Europe and Asia. The specific lot numbers affected are 105215 for Product Code 3224-E, and 100497, 100748, 101140, 102282, 102400, 102727, 102858, 103188, 103273, 103300, 103853, 104081, 104654, 104889, 105065, 105190, 105216, and 13-34 for Product Code 3226-E.
The source text does not specify the exact nature of the defect or the reason for the recall. The recall status is listed as Terminated, with a termination date of August 27, 2021. Consumers and healthcare providers should check their inventory for these specific product codes and lot numbers and contact ConvaTec for further instructions.
The recalled product
- Product
- Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
- 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 (19)
- Lot Number (Product Code 3224-E) 105215
- (Product Code 3226-E) 100497
- 100748
- 101140
- 102282
- 102400
- 102727
- 102858
- 103188
- 103273
- 103300
- 103853
- 104081
- 104654
- 104889
- 105065
- 105190
- 105216
- 13-34
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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