Maquet recalls QUADROX-i Small 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 is recalling QUADROX-i Small Oxygenators used in heart surgery because packaging flaws might let non-sterile materials touch the device, causing infections or serious complications. This affects all units sold with the specific item number.
The oxygenator packaging may have creases, holes, cracks, or dents that break the sterile seal. This could let non-sterile materials touch the device during surgery, potentially causing infections, inflammation, or other serious complications.
Healthcare professionals using the QUADROX-i oxygenators during heart surgery are most at risk. All units with the item number 701067905 are affected.
Check for the item number 701067905 on the packaging. The product is used during cardiopulmonary bypass procedures and sold with UDI-DI: 04058863019079.
Look for creases, holes, cracks, or dents in the packaging that might compromise the sterile seal.
This recall affects the oxygenator used during heart surgery. If you have the specific item number, contact Maquet for guidance.
Check the packaging for the item number 701067905 or the UDI-DI: 04058863019079.
The recall does not require immediate action. Check the packaging for damage and contact Maquet if you have concerns.
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-1636-2023 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1636-2023 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.
