Maquet Medical Systems recalls QUADROX-i Adult Oxygenators due to packaging defects that could expose non-sterile materials, 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 Medical Systems is recalling QUADROX-i Adult Oxygenators used in heart surgery because packaging flaws might let non-sterile materials touch the device, causing infection or serious complications. This affects all units sold with the item number 701067829.
The oxygenator packaging may have creases, holes, cracks, or dents that break the sterile seal. If the packaging isn't sterile, surgical materials could get contaminated, leading to infection or serious complications like sepsis.
Healthcare professionals using the QUADROX-i oxygenator during heart surgery are most at risk. All units sold with item number 701067829 are affected.
Check for the item number 701067829 on the packaging. The oxygenator is used during cardiopulmonary bypass surgery and is sold by Maquet Medical Systems.
Look for creases, holes, cracks, or dents in the packaging that might compromise the sterile seal.
Yes, all units sold with item number 701067829 are affected.
Damaged packaging could expose non-sterile materials, risking infection or serious complications like sepsis.
No, but you should check the packaging for damage before use. If damaged, contact Maquet Medical Systems for guidance.
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-1639-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1639-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
