Maquet recalls QUADROX-i Adult Oxygenators due to packaging defects that could cause infection or inflammation if sterile barrier is compromised.
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 Adult Oxygenators used during heart surgery because packaging flaws might let non-sterile materials touch the device, risking infection or inflammation. This affects patients undergoing cardiopulmonary bypass procedures.
The oxygenator packaging may have creases, holes, cracks, dents, or crushed areas that could break the sterile seal. If the sterile barrier is compromised, non-sterile materials might contact the device, causing infection, inflammation, or other complications.
Patients undergoing heart surgery using this oxygenator model are most at risk. Healthcare facilities that use the QUADROX-i during cardiopulmonary bypass procedures may also be affected.
Check for the model numbers HMO 70000-USA 701067820 or HMO 71000-USA 701067823 on the packaging. These oxygenators were sold with all lots from the manufacturer.
Inspect the packaging for creases, holes, cracks, dents, or crushed areas that might compromise the sterile barrier.
The packaging may have defects that could break the sterile seal, risking infection or inflammation if non-sterile materials contact the device.
The recall does not specify a remedy, so check the packaging for defects and contact the manufacturer if concerned.
The oxygenator may be safe if the packaging remains intact, but defects could cause infection risks.
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-1638-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1638-2023 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.
