QUADROX-i Small Adult Oxygenator Recall Due to Sterile Packaging Defects
Maquet is recalling QUADROX-i Small Adult Oxygenators due to packaging defects that may compromise the sterile barrier. Exposure to non-sterile product could cause infection, sepsis, and 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 is an FDA Class II recall of a critical cardiac medical device due to sterile barrier compromise that could result in serious infections including sepsis. However, no illnesses or injuries have been reported, placing it in the High severity category per the rubric for risk-of-harm products without reported injuries.
Plain-English summary
Maquet Medical Systems USA is recalling QUADROX-i Small Adult Oxygenators (Models HMO 50000-USA and HMO 51000-USA) used during cardiopulmonary bypass procedures. The recall affects all lots of these devices.
The devices are being recalled because of packaging defects that may compromise the sterile barrier. During packaging, accessories may be improperly placed, causing creases and damage to the sterile pouch. Additionally, product packaging may exhibit holes, cracks, dents, and crushed areas. These defects can allow the device to become contaminated with non-sterile material.
If a non-sterile device is used, patients may be at risk for inflammation, infection, sepsis, and ischemia. No illnesses or injuries have been reported to date.
Healthcare providers and patients currently using or who have used this product should contact Maquet Medical Systems USA or consult with their healthcare provider for further guidance.
The recalled product
- Product
- QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-compromise
- infection
- sepsis
Distribution
Distributed nationwide across the United States.
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