QUADROX-i Neonatal Oxygenator packaging may compromise sterile barrier
QUADROX-i Neonatal Oxygenators may have small pinholes in packaging that compromise the sterile barrier, potentially exposing the device to non-sterile conditions and risk of 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: This FDA Class II recall involves a risk-of-harm product where injury has not yet been reported. The potential hazards of infection and sepsis in a neonatal cardiac device are serious, matching the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
The QUADROX-i Neonatal Oxygenator (Models HMO 10000-USA and HMO 11000-USA), used during cardiopulmonary bypass procedures, is the subject of this recall. The recall applies to all lots of the affected models.
Product packaging may contain small pinholes that are not visible to the unaided eye. These pinholes can compromise the sterile barrier that protects the device.
Exposure to a non-sterile device may result in inflammation, infection, sepsis, and ischemia.
The recalled product
- Product
- QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-compromise
- infection
- sepsis
- ischemia
Distribution
Distributed nationwide across the United States.
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