Maquet recalls BEQ-HLS 7050 USA HLS Set Advanced 7.0 with possible compromised sterile barrier causing infection risks. Affected units include specific product codes and lots. Stop using immediately to avoid infection.
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Maquet is recalling certain BEQ-HLS 7050 USA heart-lung machine components due to a potential compromised sterile barrier that could lead to infection. This is serious because infections can cause sepsis or inflammation in medical procedures.
The Emergency Priming Line component may have a broken sterile seal, allowing bacteria to enter the system. This can cause infections like sepsis or inflammation during critical medical procedures.
Medical professionals using the CARDIOHELP heart-lung machine with the recalled BEQ-HLS 7050 USA HLS Set Advanced 7.0 components are most at risk. Patients undergoing heart-lung procedures could face infection if the device is used.
Check for the product code 70106.9078 on the BEQ-HLS 7050 USA HLS Set Advanced 7.0 used with CARDIOHELP heart-lung machines. Affected units include specific lot numbers listed in the recall notice.
Discontinue use of the recalled BEQ-HLS 7050 USA HLS Set Advanced 7.0 components to prevent infection risks.
The product code is 70106.9078 for the BEQ-HLS 7050 USA HLS Set Advanced 7.0.
The recall affects the CARDIOHELP heart-lung machine procedures where the recalled component is used.
Check the product code 70106.9078 and lot numbers listed in the recall notice for affected units.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1077-2024 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1077-2024 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.