Maquet recalls BEQ-RF-32-USA RotaFlow pumps with BIOLINE coating (Product Code 701047554) due to potential sterile barrier compromise. Affected units risk infection or sepsis if used without proper sterility.
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
Maquet is recalling certain RotaFlow centrifugal pumps that may have a seal issue compromising the sterile barrier. This could expose patients to infections or sepsis during medical procedures.
The pump's seal may fail, breaking the sterile barrier that protects patients from harmful pathogens. This breach could lead to infections, inflammation, or sepsis during critical medical procedures.
Healthcare professionals using these pumps during extracorporeal circulation procedures are most at risk. Patients receiving treatment with affected pumps could face infection or sepsis.
Check for Product Code 701047554 on the pump. Affected units include specific lots listed in the recall notice (3000286570, 3000325568, 3000341070, 3000355577, 3000358977).
Identify the Product Code 701047554 and affected lots listed in the recall notice.
Reach out to Maquet Medical Systems USA for guidance on next steps.
The BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating (Product Code 701047554).
Breach of the sterile barrier could expose patients to infections, inflammation, or sepsis.
Look for Product Code 701047554 and check if your pump's lot number matches the listed affected lots (3000286570, 3000325568, 3000341070, 3000355577, 3000358977).
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-0977-2024 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-0977-2024 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.
