ConvaTec Recalls Pediatric High Concentration Non-Rebreather Oxygen Tubing
ConvaTec is voluntarily recalling specific lots of pediatric non-rebreather oxygen tubing due to a Class II defect. The recall covers units distributed across the US and multiple international countries.
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 typically corresponds to a High severity score (3) when no specific hospitalization reports or Class I classification are present in the source text.
Plain-English summary
ConvaTec, Inc. is voluntarily recalling specific lots of Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E. The recall was initiated on May 10, 2017, and is classified as Class II by the FDA. The affected lot numbers are 100150, 100478, 100775, 101054, 101057, 101700, 101705, 103210, 103379, 103762, and 105485.
The source text does not specify the exact reason for the recall or the specific defect, but the FDA Class II classification indicates that the product could temporarily cause or contribute to reversible adverse health consequences. The recall status is currently terminated as of August 27, 2021.
The affected products were distributed to various states in the United 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. 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 providers should check their inventory for these specific lot numbers and contact ConvaTec for further instructions.
The recalled product
- Product
- Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Oxygen Tubing
- 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 100150
- 100478
- 100775
- 101054
- 101057
- 101700
- 101705
- 103210
- 103379
- 103762
- 105485
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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