Maquet recalls HLS Set Advanced 7.0 devices (model BEQ-HLS 7050) due to sterility barrier breaches. These devices are used for cardiac support. Affected units include specific lot codes.
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Maquet is recalling HLS Set Advanced 7.0 devices (model BEQ-HLS 7050) because their sterility barrier may be breached. This could lead to infections during medical procedures. Patients using these devices for cardiac support should contact Maquet for details.
The sterility barrier in these devices may be breached, allowing contaminants to enter the device. This could lead to infections during medical procedures if the device is used without proper sterility.
Healthcare professionals using the HLS Set Advanced 7.0 devices for cardiac support are most at risk. Patients receiving this device for temporary cardiac or pulmonary support may also be affected.
Check for the model BEQ-HLS 7050 and product code 70105.2794. Affected units include specific lot codes: 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, 70135038.
Look for the lot code on the device packaging or label to determine if it's affected.
Reach out to Maquet for guidance on next steps if the device is affected.
The product code is 70105.2794.
Affected lot codes include 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, and 70135038.
Check the lot code on the device packaging or label. If it matches the affected lot codes listed, the device is recalled.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0633-2021 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0633-2021 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.
