Maquet recalls QUADROX-iR cardiopulmonary bypass devices due to packaging defects that could compromise sterility, risking infection and inflammation. Affected units have specific model numbers and item numbers.
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Maquet is recalling QUADROX-iR devices used during cardiopulmonary bypass surgery because packaging flaws may damage the sterile barrier. This could lead to infections or other complications if non-sterile materials come into contact with the device.
The packaging may have creases, holes, cracks, dents, or crushed areas that damage the sterile barrier. This could allow non-sterile materials to contact the device, potentially causing inflammation, infection, sepsis, or tissue damage.
Healthcare professionals using the QUADROX-iR devices during surgery are most at risk. Patients receiving these devices during cardiopulmonary bypass procedures may be affected if the packaging is compromised.
Check for model numbers on the device: BEQ-HMO 51100-USA (701067936), BEQ-HMO 71100-USA (701067880), HMO 50100-USA (701067934), HMO 51100-USA (701067938), HMO 70100-USA (701067874), or HMO 71100-USA (701067886). All lots of these models are affected.
Inspect the packaging for creases, holes, cracks, dents, or crushed areas that could compromise sterility.
The affected models are BEQ-HMO 51100-USA (701067936), BEQ-HMO 71100-USA (701067880), HMO 50100-USA (701067934), HMO 51100-USA (701067938), HMO 70100-USA (701067874), and HMO 71100-USA (701067886).
The recall record does not specify a remedy, so no action is required beyond checking the packaging for damage.
The recall states that compromised packaging could lead to infection or inflammation, but the device itself is not considered a direct hazard in normal use.
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-1643-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1643-2023 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.
