BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. 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 has expanded a recall of the BEQ-HLS 7050 HLS Set Advanced 7.0, a preconnected sterile set used for extracorporeal respiratory and cardiovascular support as part of the CARDIOHELP system. The recall addresses a potential breach in the sterility barrier that may result in compromised product sterility. This is an expansion of a prior recall initiated on November 6, 2020.
The affected product has been distributed worldwide, including 206 units in the US and 48,960 units total across the US, Canada, and Australia. The recall involves specific lot numbers: 3000183172, 3000183179, 3000183191, 3000183910, and 3000184681 (UDI-DI: 04037691741543). The source document does not specify a remedy or 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: 04037691741543 Lots 3000183172, 3000183179, 3000183191, 3000183910, 3000184681
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.