QUADROX-iD Adult Oxygenator recalled for packaging defect compromising sterile barrier
Maquet Medical Systems USA recalls 24,250 QUADROX-iD Adult Oxygenators due to small pinholes in product packaging that may compromise the sterile barrier, potentially exposing patients to non-sterile devices during cardiopulmonary bypass surgery.
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 a Class II FDA recall involving a critical surgical device with potential for serious infection (sepsis) and tissue damage (ischemia) if the sterile barrier is compromised. No illnesses or injuries have been reported in the source text.
Plain-English summary
Maquet Medical Systems USA is recalling 24,250 QUADROX-iD Adult Oxygenators (Model HMOD 70000-USA and BEQ-HMOD70000-USA) used during cardiopulmonary bypass procedures. The recalled oxygenators have small pinholes in their product packaging that may not be visible to the naked eye.
These pinholes can compromise the sterile barrier of the packaging, potentially exposing the device to non-sterile conditions. If a patient receives a contaminated device, they may face serious complications including inflammation, infection, sepsis, and ischemia.
The recalled devices were distributed nationwide in the United States. Hospitals and healthcare facilities that use these devices should contact Maquet Medical Systems USA immediately to determine if they have received affected units and follow the manufacturer's instructions for handling or replacement of recalled products.
The recalled product
- Product
- QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-compromise
- infection
- sepsis
- ischemia
Distribution
Distributed nationwide across the United States.
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