Maquet recalls QUADROX-i Small Adult Oxygenators due to packaging defects that could expose non-sterile materials, risking infection during surgery. Affected units have specific model numbers and serials.
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-i Small Adult Oxygenators used in heart surgery because packaging flaws might let non-sterile materials touch the device, causing infections or other serious health issues. This affects specific model numbers and serials sold in the U.S.
The oxygenator packaging can develop creases, holes, cracks, or dents during shipping. If the packaging isn't sterile, it could expose the device to non-sterile materials, leading to infections, inflammation, or other complications during surgery.
Healthcare professionals using the QUADROX-i oxygenators during heart surgery are most at risk. Patients undergoing cardiopulmonary bypass procedures may be affected if the device is used on faulty packaging.
Check for model numbers HMO 50000-USA or HMO 51000-USA with serial numbers starting with 701067891 or 701067895. All units sold in the U.S. with these model and serial combinations are affected.
Inspect the packaging for creases, holes, cracks, or dents that might compromise sterility.
The packaging may have defects that could expose the oxygenator to non-sterile materials, risking infection during surgery.
Model numbers HMO 50000-USA and HMO 51000-USA with serial numbers starting with 701067891 or 701067895.
No. The recall focuses on packaging defects, not the device itself. Check packaging for damage before use.
We’ve drafted a message you can send Maquet Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1637-2023 — Maquet Medical Maquet Medical Hello, I own a Maquet Medical that is covered by recall Z-1637-2023 from Maquet Medical. 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.
