BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Check against the official notice below — it lists the full affected range.
Maquet Medical Systems USA is expanding a recall of the BEQ-HLS 5050 HLS Set Advanced 5.0 (Part No. 70105.2797), a preconnected set used for extracorporeal respiratory and cardiovascular support as part of the CARDIOHELP system. The recall was originally initiated on November 6, 2020, and has now been expanded due to a potential breach in the sterility barrier that may result in compromised product sterility.
The affected product has been distributed worldwide, including throughout the United States, Canada, and Australia. In the US, 206 units are affected, with 48,960 units affected worldwide. The recalled lot/code information is UDI-DI: 04037691773513 Lot 3000183908. The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). Distribution: Worldwide distribution - US Nationwide and the countries Canada and Australia. Quantity: 206 US; 48,960 Worldwide Lot/code info: UDI-DI: 04037691773513 Lot 3000183908
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.