Maquet recalls QUADROX -i neonatal oxygenators with packaging defects that could cause infection. Affected units have specific model numbers and serials; contact for repair or replacement.
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 neonatal oxygenators that may have packaging defects. These defects could allow non-sterile materials to enter the device, risking infection or serious complications for infants during surgery.
The packaging may have creases, holes, cracks, or dents that compromise the sterile barrier. This could expose the oxygenator to non-sterile materials, leading to infection, inflammation, sepsis, or tissue damage in infants.
Healthcare providers using the QUADROX -i oxygenators for neonatal patients. Infants undergoing cardiopulmonary bypass surgery are most at risk due to potential infection.
Check for model numbers HMO 10000-USA (serial 701070412) or HMO 11000-USA (serial 701070416) on the packaging. All lots are affected.
Inspect for creases, holes, cracks, or dents in the packaging that might compromise sterility.
The packaging may have defects that could allow non-sterile materials to enter the oxygenator, risking infection or serious complications for infants.
Check the packaging for defects and contact Maquet for guidance on next steps.
Yes: HMO 10000-USA (serial 701070412) and HMO 11000-USA (serial 701070416). All lots are affected.
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-1640-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1640-2023 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.
