Maquet recalls HMOD 70000-USA/QUADROX-iD Adult Oxygenators due to packaging defects that could compromise sterility, risking infection during surgery. All units are affected.
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 its HMOD 70000-USA/QUADROX-iD Adult Oxygenators because packaging flaws might allow non-sterile materials to contact the device, increasing infection risk during surgery. This affects all units sold.
The oxygenator packaging may have creases, holes, cracks, dents, or crushed areas that break the sterile seal. This could let non-sterile materials touch the device, causing infection, inflammation, or other complications during surgery.
Surgical teams using the HMOD 70000-USA/QUADROX-iD Oxygenators during cardiopulmonary bypass procedures are affected. Patients undergoing surgery with this device face the highest risk of infection.
Check for the product name 'HMOD 70000-USA/QUADROX-iD Adult Oxygenator' and item number 701067840. All units sold are affected, with no specific lot or date restrictions.
Inspect the packaging for creases, holes, cracks, dents, or crushed areas that might compromise sterility.
Yes, all units of the HMOD 70000-USA/QUADROX-iD Adult Oxygenator with item number 701067840 are affected.
The official recall notice does not specify a remedy for damaged packaging; check with your healthcare provider for guidance.
The recall does not provide a remedy to continue using the device; affected units should be checked for packaging integrity.
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-1634-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1634-2023 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.
