Maquet recalls HLS Set Advanced 5.0 models with product code 70105.2797 due to sterility barrier breaches that could cause infections during cardiac surgery.
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Maquet is recalling its HLS Set Advanced 5.0 models (product code 70105.2797) because the sterile packaging may have been compromised, risking infections during cardiac surgery. This is serious for patients undergoing heart or lung support procedures.
The sterility barrier in the device's packaging may have been breached, allowing contaminants to enter the sterile system. This could lead to infections during critical cardiac or pulmonary support procedures where the device is used.
Healthcare professionals using the device with the CARDIOHELP system for cardiac or pulmonary support are affected. Patients undergoing heart or lung support procedures are at risk of infection if the device is used.
Check for the model name BEQ-HLS 5050 USA or the product code 70105.2797 on the device packaging. The lot codes listed in the recall include specific numbers like 70127790 through 70136152.
Look for the model name BEQ-HLS 5050 USA or product code 70105.2797 on the device packaging.
Reach out to Maquet Cardiovascular US Sales, LLC for instructions on how to handle the device if it is recalled.
The sterility barrier in the device's packaging may have been breached, risking infections during cardiac or pulmonary support procedures.
Check the device packaging for the model name BEQ-HLS 5050 USA or product code 70105.2797. Contact Maquet Cardiovascular US Sales, LLC for instructions.
The recall is due to potential sterility breaches that could cause infections, not immediate physical injury risks.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0632-2021 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0632-2021 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.
