Maquet QUADROX-iR Cardiopulmonary Bypass Device Recalled for Packaging Damage
Maquet Medical Systems USA is recalling QUADROX-iR cardiopulmonary bypass devices due to damaged packaging that may compromise sterility. This could result in infection, sepsis, or 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: FDA Class II medical device with sterile-barrier compromise risk in critical surgical application. The hazard is theoretical (potential infection and sepsis) with no reported illnesses in the source, qualifying as a risk-of-harm product without reported injury per the FDA severity rubric.
Plain-English summary
Maquet Medical Systems USA is recalling QUADROX-iR cardiopulmonary bypass devices used during heart-lung bypass surgery. Affected models include BEQ-HMO 51100-USA, BEQ-HMO 71100-USA, HMO 50100-USA, HMO 51100-USA, HMO 70100-USA, and HMO 71100-USA, available with or without integrated filters and with BIOLINE or SOFTLINE coatings. All lot numbers distributed nationwide are included in this recall.
The recall addresses packaging defects that may compromise device sterility. During production, an accessory may be improperly placed, causing creases and damage to the sterile pouch. Additionally, packaging may develop holes, cracks, dents, and crushed areas. These defects can breach the sterile barrier, potentially exposing the device to non-sterile conditions.
Exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
The recalled product
- Product
- QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 5
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-compromise
- packaging-damage
- infection-risk
- ischemia-risk
Distribution
Distributed nationwide across the United States.
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