QUADROX-i Small Adult Oxygenator Recalled Due to Packaging Sterile Barrier Defect
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Adult Oxygenators used in heart bypass surgery because product packaging may contain tiny pinholes that compromise sterile integrity, potentially allowing non-sterile exposure.
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 for a sterile barrier compromise in a surgical medical device with serious potential consequences (infection, sepsis, ischemia). No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Maquet Medical Systems USA is recalling 1,784 QUADROX-i Small Adult Oxygenators used during cardiopulmonary bypass surgery. The affected models include BEQ-HMO 50000-USA, HMO 50000-USA, and HMO 51000-USA, distributed nationwide in the United States.
Product packaging may contain small pinholes that are not visible to the unaided eye. These defects can compromise the sterile barrier of the packaging, potentially allowing the device to be exposed to non-sterile conditions before surgical use.
If a non-sterile device is used during surgery, patients may experience inflammation, infection, sepsis, or ischemia. Healthcare facilities currently holding affected devices should stop using them immediately and contact Maquet Medical Systems USA for return or replacement instructions.
The recalled product
- Product
- QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-compromise
- infection
- sepsis
- ischemia
Distribution
Distributed nationwide across the United States.
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