Maquet recalls Venous Hardshell Cardiotomy Reservoirs with packaging defects that could cause infection. Affected units have specific model numbers and serials. Stop using if packaging shows damage.
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 Venous Hardshell Cardiotomy Reservoirs used during heart surgery because packaging flaws might let non-sterile materials touch the device, causing infection. This is serious for patients undergoing heart surgery.
The packaging may have creases, holes, cracks, dents, or crushed areas. This breaks the sterile seal, allowing non-sterile materials to contact the device. This could lead to infection, inflammation, or other complications during surgery.
Healthcare professionals using the device during cardiopulmonary bypass procedures. Patients undergoing heart surgery are at risk if the device is used with damaged packaging.
Check for model numbers VKMO 10000-USA (701070441) or VKMO 11000-USA (701070445) on the packaging. All lots are affected. Look for packaging damage like holes, cracks, or dents.
Inspect the packaging for creases, holes, cracks, dents, or crushed areas that could compromise sterility.
The product may be unsafe if packaging is damaged. Always check for packaging defects before use.
The official recall notice does not specify a remedy. Check packaging for damage and stop use if defects are found.
Look for model numbers VKMO 10000-USA (701070441) or VKMO 11000-USA (701070445) on the packaging. All lots are affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1642-2023 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1642-2023 from Maquet. 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.
