ConvaTec Recalls Pediatric Non-Rebreather Oxygen Masks Due to Defects
ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen masks with tubing. The recall was initiated by the firm and is currently terminated.
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 or for high-risk scenarios without confirmed illness.
Plain-English summary
ConvaTec, Inc. is voluntarily recalling specific lots of Non-Rebreather Oxygen Masks, Pediatric with Tubing. The affected products include Product Codes 86-3226E, PMD06009, and PMD06106. The recall was initiated by the firm on May 10, 2017, and was classified as Class II by the FDA. The recall status is currently terminated.
The source text does not specify the exact reason for the recall or the specific defect involved. The affected units 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 countries including 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.
Consumers who have 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
- Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106
- Manufacturer
- ConvaTec, Inc
- 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 (11)
- Lot Number (Product Code 86-3226E) 100050
- 100196
- 102698
- 103003
- 104062
- 104331
- 104424
- 104928
- 105597
- (Product Code PMD06009) 100574
- (Product Code PMD06106) 100581
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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