QUADROX-iD Pediatric Oxygenator Recalled Due to Packaging Sterile Barrier Defect
Maquet Medical Systems USA recalls 5,022 QUADROX-iD Pediatric Oxygenators distributed nationwide due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices.
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 real packaging defect with potential for serious harm including sepsis and ischemia. While no illnesses have been reported, the product represents a risk-of-harm situation where injury has not yet been reported, matching the High severity category.
Plain-English summary
Maquet Medical Systems USA is recalling 5,022 QUADROX-iD Pediatric Oxygenators distributed nationwide. The product is an oxygenator used during cardiopulmonary bypass procedures.
Product packaging may contain small pinholes that are not visible to the unaided eye. These pinholes can compromise the sterile barrier of the packaging, potentially allowing the device to become non-sterile.
Exposure to a non-sterile device may result in inflammation, infection, sepsis, and ischemia.
The recalled product
- Product
- QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
- Manufacturer
- Maquet Medical Systems USA
- Affected units
- 5,022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Maquet Medical Systems USA 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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