QUADROX-iR Heart-Lung Oxygenator Recalled for Sterile Barrier Packaging Defect
Maquet Medical is recalling QUADROX-iR oxygenators used in heart-lung bypass procedures due to potential pinholes in packaging that may compromise the sterile barrier, creating risk of serious infection.
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: FDA Class II recall involving potential sterile barrier compromise on a critical medical device. No illnesses reported, but the risk of serious infection and sepsis on cardiopulmonary bypass equipment justifies High severity.
Plain-English summary
Maquet Medical Systems USA is recalling multiple models of the QUADROX-iR oxygenator, a medical device used during cardiopulmonary bypass procedures. The affected models are: BEQ-HMO 51100-USA, BEQ-HMO 71100-USA, HMO 50100-USA, HMO 51100-USA, HMO 70100-USA, and HMO 71100-USA, affecting all production lots.
The problem: the product packaging may contain small pinholes that are not visible to the naked eye. These defects compromise the sterile barrier intended to protect the device from contamination.
Exposure to a non-sterile device carries serious risks, including inflammation, infection, sepsis, and ischemia. The affected products have been distributed nationwide. Healthcare providers and medical facilities using these devices should contact Maquet Medical Systems USA immediately for recall instructions.
The recalled product
- Product
- QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-compromise
- infection
- sepsis
- ischemia
Distribution
Distributed nationwide across the United States.
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