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Maquet Cardiovascular Us Sales, Llc Recall: HLS Set Advanced Model Name: BEQ-HLS 5050 USA;

Maquet Cardiovascular Us Sales, Llc Recall: HLS Set Advanced Model Name: BEQ-HLS 5050 USA; is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Maquet Cardiovascular Us Sales, Llc; Product: HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.

Recalling firmMaquet Cardiovascular Us Sales, Llc
ProductHLS 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.
Reason for recallThe HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide 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 Ko
Recall initiated20201120
Recall numberZ-0632-2021
Categorydevice
StateNJ
CountryUnited States

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