HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - 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 5050 (Part Number 70105.2797), a disposable device used with the Cardiohelp system. The recall affects 58,438 devices worldwide due to breaches in the product's sterility barrier. The devices were distributed nationwide in the United States and in numerous countries including Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, India, Italy, Japan, and many others.
The affected devices can be identified by checking whether your lot code matches one of the 128 specific lot codes listed in this recall. The recall notice does not specify any remedy or instructions for what affected consumers should do.
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: 58,438 devices worldwide Lot/code info: Model Number: BEQ-HLS 5050 Part Number: 70105.2797 UDI Code: 04037691773513 Lot Codes: 70127790, 70127791, 70127792, 70127793, 70127921, 70127922, 70127923, 70127924, 70128195, 70128196, 70128197, 70128328, 70128329, 70128330, 70128331, 70129242, 70129243, 70129244, 70129245, 70129380, 70129381, 70129382, 70129383, 70129469, 70129470, 70129471, 70129472, 70129556, 70129557, 70129558, 70129559, 70129634, 70129635, 70129637, 70129638, 70129849, 70129850, 70130071, 70130072, 70130207, 70130208, 70130209, 70130883, 70130884, 70130885, 70130886, 70131090, 70131091, 70131092, 70131093, 70131159, 70131160, 70131161, 70131162, 70131405, 70131406, 70131407, 70131408, 70131474, 70131475, 70131587, 70131588, 70131589, 70131590, 70131976, 70131977, 70131978, 70131979, 70132435, 70132652, 70132653, 70132845, 70132861, 70132862, 70132903, 70132904, 70133056, 70133057, 70133102, 70133103, 70133472, 70133473, 70133474, 70133475, 70133528, 70133634, 70133636, 70133637, 70133751, 70133752, 70133753, 70133754, 70133755, 70133756, 70133757, 70133758, 70133759, 70133760, 70133761, 70133762, 70133763, 70133764, 70134019, 70134020, 70134021, 70134022, 70134023, 70134025, 70134028, 70134750, 70134751, 70134752, 70134753, 70134754, 70134755, 70135250, 70135251, 70135252, 70135253, 70135254, 70135255, 70135256, 70135257, 70135258, 70136150, 70136151, 70136152
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.