Maquet recalls BEQ-HLS 7050 USA and HLS Set Advanced 7.0 sets due to potential sterility barrier breaches that could compromise product sterility. Affected units include specific lot numbers from November 2020.
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
Maquet is recalling certain extracorporeal respiratory sets that may have a sterility barrier breach, risking infection during medical use. This is serious for patients needing life support.
The sterility barrier in the set may be compromised, allowing contaminants to enter the medical device. This could lead to infections in patients who require extracorporeal respiratory support, such as those on life support systems.
Healthcare professionals using the BEQ-HLS 7050 USA and HLS Set Advanced 7.0 sets for extracorporeal respiratory support are most at risk. Patients receiving this life-saving treatment could face infection if the set is used without proper sterility.
Check for the model 'BEQ-HLS 7050 USA' or 'HLS Set Advanced 7.0' with part number 70106.9078. Affected units include specific lot numbers listed in the recall notice.
Identify the model and part number to confirm if your set is affected by the recall.
Reach out to Maquet Medical Systems USA for guidance on next steps if your set is affected.
No, this recall is for medical use only in hospitals and clinical settings.
Check the model name, part number, and lot numbers listed in the recall notice.
Contact Maquet Medical Systems USA for instructions on next steps.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1767-2022 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1767-2022 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.