BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. 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 recalling the HLS Set Advanced 7.0, a preconnected sterile set used for extracorporeal respiratory and/or cardiovascular support as part of the CARDIOHELP system. This is an expanded recall of a product originally recalled on November 6, 2020. The recall affects 6,871 units in the United States and 18,670 units worldwide across the US, Canada, and Australia due to a potential breach in the sterility barrier that may compromise the product's sterility.
The affected lot numbers are identified by UDI-DI 04058863080383 and include numerous specific lot codes ranging from 3000190535 through 3000234522. The source document does not specify a remedy or recommended action for consumers who may have received this product.
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: 6,871 US; 18,670 worldwide Lot/code info: UDI-DI: 04058863080383 Lots 3000190535, 3000190536, 3000190537, 3000192076, 3000192077, 3000192078, 3000192079, 3000193358, 3000193359, 3000193360, 3000193361, 3000193362, 3000195061, 3000195062, 3000195063, 3000195064, 3000195065, 3000195066, 3000195067, 3000196193, 3000196195, 3000196196, 3000196197, 3000196198, 3000196199, 3000197830, 3000197831, 3000197833, 3000197837, 3000197839, 3000199069, 3000199071, 3000199072, 3000199073, 3000199074, 3000199077, 3000200108, 3000200110, 3000200111, 3000200112, 3000200113, 3000202025, 3000202027, 3000202029, 3000202030, 3000202031, 3000203092, 3000203093, 3000204058, 3000204156, 3000204157, 3000204284, 3000205878, 3000205879, 3000205880, 3000207510, 3000208687, 3000208692, 3000210629, 3000210630, 3000215200, 3000215238, 3000216174, 3000216177, 3000220057, 3000220062, 3000221755, 3000221756, 3000221757, 3000224126, 3000224134, 3000227577, 3000227580, 3000228336, 3000228337, 3000228338, 3000228804, 3000228805, 3000228864, 3000232543, 3000234522
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.