Maquet recalls QUADROX-i Pediatric Oxygenators due to packaging defects that could compromise sterile barriers, risking infection. Affected units include specific model numbers and lots.
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 Pediatric Oxygenators used during heart surgery because packaging flaws might allow non-sterile materials to contact the device, increasing infection risk. This is serious for patients undergoing cardiopulmonary bypass procedures.
The packaging can develop creases, holes, cracks, or dents during shipping, breaking the sterile seal. If the sterile barrier is compromised, non-sterile materials could contact the oxygenator, leading to infection, inflammation, or sepsis in patients.
Patients undergoing heart surgery using this oxygenator are most at risk. Healthcare providers who use the device during cardiopulmonary bypass procedures may also be affected.
Check for model numbers HMO 30000-USA (701070384) or HMO 31000-USA (701070388) on the packaging. All lots of these models are affected.
Inspect the packaging for creases, holes, cracks, or dents that might compromise the sterile barrier.
The packaging may have defects that break the sterile seal, risking infection during surgery.
The recall record does not specify a remedy, so contact Maquet Medical Systems USA directly for guidance.
Yes, models HMO 30000-USA (701070384) and HMO 31000-USA (701070388) are affected across all lots.
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-1641-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1641-2023 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.
