ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Valve Defect
ConvaTec is recalling specific lots of pediatric oxygen masks because the check valve may not function correctly, potentially affecting oxygen delivery.
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, and the hazard involves a medical device that may fail to deliver the intended oxygen concentration, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
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 Check Valve, One Side Valve, Product Code 3230-E. The recall was initiated on May 10, 2017, and was classified as Class II by the FDA. The reason for the recall is that the check valve on the oxygen tubing may not function correctly, which could result in the mask not delivering the intended concentration of oxygen to the patient.
The affected product was distributed in the United States (CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA, 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. The specific lot numbers subject to the recall are 100214, 100316, 100467, 101619, 102605, 102728, 103190, 103451, 103852, 104083, 104905, and 105142.
Healthcare providers and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to ConvaTec, Inc. according to the instructions provided in the recall letter. The recall was terminated on August 27, 2021.
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 Check Valve, One Side Valve, Product Code 3230-E
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Oxygen Therapy
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 (12)
- Lot Number 100214
- 100316
- 100467
- 101619
- 102605
- 102728
- 103190
- 103451
- 103852
- 104083
- 104905
- 105142
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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