Maquet recalls BEQ-HLS 5050 USA and HLS Set Advanced 5.0 sets due to potential sterility barrier breach. This could compromise product sterility, risking infection during extracorporeal respiratory support. Affected units include specific lot numbers.
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 because a potential breach in the sterility barrier could lead to compromised product sterility. This risk is serious for medical use, as it might cause infections during life-support procedures.
The sterility barrier in these medical sets might be compromised, leading to contamination. This could cause infections in patients during critical extracorporeal respiratory support procedures.
Healthcare providers using the BEQ-HLS 5050 USA or HLS Set Advanced 5.0 sets for extracorporeal respiratory support are most at risk. Patients receiving this life-support treatment could be affected if the recalled sets are used.
Check for the model name 'BEQ-HLS 5050 USA' or 'HLS Set Advanced 5.0' with part number 70106.9077. Affected units include specific lot numbers: 3000192081, 3000193363, 3000196200, 3000208697, 3000216172.
Identify the model name and part number to confirm if your set is affected.
Reach out to Maquet Medical Systems USA for further assistance or to confirm if your set is recalled.
The recall is due to a potential breach in the sterility barrier that could compromise product sterility, risking infections during extracorporeal respiratory support.
The affected product is the BEQ-HLS 5050 USA or HLS Set Advanced 5.0 with part number 70106.9077.
Check for the model name and part number. Affected units include specific lot numbers: 3000192081, 3000193363, 3000196200, 3000208697, 3000216172.
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-1766-2022 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1766-2022 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.
