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 part numbers and lots.
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 means the sets might not be safe for medical use if they become contaminated.
The sterility barrier in the set could be breached, allowing contaminants to enter the system. This might compromise the product's sterility, making it unsafe for medical use during extracorporeal respiratory support.
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 treatment with these sets could be affected if the sterility barrier is compromised.
Check for the product name 'BEQ-HLS 7050 USA' or 'HLS Set Advanced 7.0' with part number 70105.2794. Affected units include specific lots: 3000183172, 3000183179, 3000183191, 3000183910, 3000184681.
Identify the product name, part number, and lot numbers listed in the recall notice to confirm if your unit is affected.
The recall is due to a potential breach in the sterility barrier that could compromise product sterility, as noted in the expanded recall initiated November 6, 2020.
The recall notice does not specify a remedy, so check the product details to confirm if your unit is affected and contact Maquet Medical Systems for further instructions.
Yes, affected lots include 3000183172, 3000183179, 3000183191, 3000183910, and 3000184681.
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-1764-2022 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1764-2022 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.
