Maquet recalls QUADROX-iR cardiopulmonary bypass devices due to potential pinholes in packaging that could compromise sterility, risking infection and inflammation.
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Maquet is recalling QUADROX-iR devices used during cardiopulmonary bypass surgery because packaging may have small pinholes that aren't visible to the naked eye. This could allow non-sterile materials to enter the device, causing infections, inflammation, or other serious health issues.
The packaging for these medical devices may have small pinholes that are not visible without magnification. If these pinholes exist, non-sterile materials could enter the device, leading to infections, inflammation, or other serious complications.
Healthcare professionals using QUADROX-iR devices during cardiopulmonary bypass surgery are most at risk. Patients receiving these devices during surgery could be affected if the packaging is compromised.
Check for the model numbers BEQ-HMO 51100-USA, BEQ-HMO 71100-USA, HMO 50100-USA, HMO 51100-USA, HMO 70100-USA, or HMO 71100-USA on the packaging. These devices were sold with specific item numbers and are used during cardiopulmonary bypass procedures.
Look for model numbers BEQ-HMO 51100-USA, BEQ-HMO 71100-USA, HMO 50100-USA, HMO 51100-USA, HMO 70100-USA, or HMO 71100-USA to identify affected devices.
The packaging may have small pinholes that are not visible to the naked eye, which could compromise the sterile barrier and lead to infections or inflammation.
The recall record does not specify a remedy, so contact Maquet Medical Systems USA for guidance on next steps.
Yes, if the packaging is compromised, exposure to non-sterile materials could cause inflammation, infection, sepsis, or ischemia.
We’ve drafted a message you can send Maquet Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1662-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1662-2023 from Maquet Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
