HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
Check against the official notice below — it lists the full affected range.
Maquet Cardiovascular US Sales, LLC is recalling the HLS Set Advanced (Model BEQ-HLS 7050, Part Number 70105.2794), a disposable component used with the CARDIOHELP system. The recall was initiated because the product's sterility barrier has been breached, which compromises the sterile condition necessary for safe use of the device. The affected product includes specific lot codes: 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, and 70135038.
The recalled device has been distributed worldwide, including throughout the United States and in numerous countries across Europe, Asia, South America, the Middle East, and other regions. According to the recall notice, no remedy information has been specified in the available record regarding what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
Reason for recall: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier. Distribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Australia, Austria, Belgium, Brazil, Brunei Darussal, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Quantity: N/A Lot/code info: Model Number: BEQ-HLS 7050 Part Number: 70105.2794 UDI Code: 04037691773513 Lot Codes: 70130364, 70132269, 70133476, 70133592, 70133623, 70133624, 70133625, 70134790, 70135038
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.