QUADROX-i Pediatric Oxygenators Recalled for Packaging Sterility Defects
QUADROX-i Pediatric Oxygenators used in cardiopulmonary bypass surgery are recalled for packaging defects that may compromise sterility, potentially causing inflammation, infection, sepsis, or ischemia.
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: No illnesses or injuries are reported. This is a risk-of-harm medical device with potential for serious consequences (sepsis, ischemia) but without reported incidents. This meets High severity criteria.
Plain-English summary
Maquet Medical Systems USA is recalling QUADROX-i Pediatric Oxygenators used during cardiopulmonary bypass surgery. The affected models are HMO 30000-USA (Item No. 701070384) and HMO 31000-USA (Item No. 701070388), with all lots distributed nationwide.
The product packaging may contain small pinholes that are not visible to the naked eye. These defects compromise the sterile barrier of the packaging, potentially exposing the device to non-sterile conditions.
Exposure to a non-sterile device may result in inflammation, infection, sepsis, and ischemia in patients undergoing cardiopulmonary bypass surgery who receive the affected device.
The recalled product
- Product
- QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-defect
- infection
- sepsis
- ischemia
Distribution
Distributed nationwide across the United States.
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