Maquet Medical Systems USA recalls Model BEQ-HLS 5050 USA HLS Set Advanced 5.0 (Product Code 70106.9077) used with CARDIOHELP. The Emergency Priming Line may have a compromised sterile barrier, risking infection or sepsis. Affected units include specific lots.
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 Medical Systems recalls certain HLS Sets Advanced 5.0 models used with CARDIOHELP due to a potential compromised sterile barrier in the Emergency Priming Line. This could lead to infection or sepsis if the device is used without proper sterilization.
The Emergency Priming Line component may have a weakened sterile seal due to manufacturing defects. This could allow contaminants to enter the device, causing infections or sepsis in patients during medical procedures.
Healthcare professionals using the CARDIOHELP heart-lung machine with the recalled HLS Set Advanced 5.0 models are most at risk. Patients receiving treatment with these devices could be affected if the sterile barrier is compromised.
Check for the model number BEQ-HLS 5050 USA, product code 70106.9077, and specific lots listed: 3000301222, 3000319782, 3000327602, 3000333098, 3000352360, 3000357174. The device is used with the CARDIOHELP heart-lung machine.
Look for the lot numbers 3000301222, 3000319782, 3000327602, 3000333098, 3000352360, or 3000357174 on the product label.
Reach out to Maquet Medical Systems USA for guidance on next steps if you have the recalled product.
The recalled model is BEQ-HLS 5050 USA, HLS Set Advanced 5.0 with product code 70106.9077.
Check for the lot numbers 3000301222, 3000319782, 3000327602, 3000333098, 3000352360, or 3000357174 on the product label, and confirm it is used with the CARDIOHELP heart-lung machine.
Contact Maquet Medical Systems USA for guidance on next steps if you have the recalled product.
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-1076-2024 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1076-2024 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.
