QUADROX-i Neonatal oxygenator recalled for compromised sterile packaging
Maquet Medical Systems is recalling QUADROX-i Neonatal oxygenators due to packaging defects that may compromise sterility. Improper accessory placement and packaging damage could expose the device to contamination, risking infection and sepsis.
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 device with theoretical risk of serious infection and sepsis if sterile barrier is compromised. No reported illnesses or injuries in the source. Qualifies as High severity because it presents a significant risk of harm in critical-care medical equipment, but without documented incidents.
Plain-English summary
Maquet Medical Systems USA is recalling QUADROX-i Neonatal oxygenators, models HMO 10000-USA and HMO 11000-USA, nationwide. These devices are oxygenators used during cardiopulmonary bypass procedures to oxygenate blood.
The recall was initiated due to packaging defects that may compromise the sterile barrier. An accessory may be improperly placed during packaging, causing creases and damage to the sterile pouch. Product packaging may also exhibit holes, cracks, dents, and crushed areas. These defects compromise the packaging's ability to maintain sterility.
Exposure of the product to non-sterile conditions may result in inflammation, infection, sepsis, or ischemia. All lots of the affected models are included in this nationwide recall.
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
- Category
- Medical Device — Oxygenator
- Hazard
- contamination
- infection
- sepsis
- ischemia
Distribution
Distributed nationwide across the United States.
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