FDA (Devices) recall action 90740
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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).
The agency’s own wording, quoted from the enforcement report.
Maquet Medical Systems USA is recalling the BEQ-HLS 5050 (HLS Set Advanced 5.0) due to a potential breach in the sterility barrier that may compromise product sterility.
Maquet Medical Systems USA has expanded a recall for HLS Set Advanced 7.0, a preconnected medical device used for heart and lung support, due to a potential breach in the sterility barrier that could compromise product sterility.
Maquet Medical Systems is expanding its recall of the CARDIOHELP HLS Set Advanced due to a potential breach in the sterility barrier that could compromise product sterility, affecting 6,871 US units and 18,670 worldwide.
Maquet Medical Systems USA is recalling HLS Set Advanced 5050 units due to a potential breach in the sterility barrier. The defect may result in compromised product sterility for this cardiac and respiratory support equipment.