Maquet Medical Systems recalls HLS Set Advanced 5.0 (Part No. 70105.2797) due to potential sterility barrier breach. This could compromise product sterility for extracorporeal respiratory support.
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 Medical Systems is recalling their HLS Set Advanced 5.0 (Part No. 70105.2797) because of a potential breach in the sterility barrier. This could lead to compromised product sterility, which is especially concerning for medical devices used in extracorporeal respiratory support.
The sterility barrier in the device may be breached, potentially compromising product sterility. This could lead to infections or other complications if the device is used without proper sterility.
Healthcare professionals using the HLS Set Advanced 5.0 for extracorporeal respiratory support are most at risk. The recall applies to the specific model and part number listed.
Check for the model name 'HLS Set Advanced 5.0' and part number '70105.2797'. The device is used for extracorporeal respiratory and/or cardiovascular support in the CARDIOHELP System.
Look for the model name 'HLS Set Advanced 5.0' and part number '70105.2797' on the device.
The recall is due to a potential breach in the sterility barrier that may result in compromised product sterility.
The recalled product is the HLS Set Advanced 5.0 with part number 70105.2797.
The recall record does not specify a remedy.
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-1765-2022 — Maquet Medical Systems Maquet Medical Systems Hello, I own a Maquet Medical Systems that is covered by recall Z-1765-2022 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.
