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Home » FDA Labels Datascope/Getinge, Emergent Device Recalls as Class 1
FDA Labels Datascope/Getinge, Emergent Device Recalls as Class 1
The FDA issued updates on recalls of Datascope/Getinge’s Cardiosave Hybrid and Rescue intra-aortic balloon pumps (IABP) and certain Emergent reactive skin decontamination lotion (RSDL) kits, declaring them to be Class 1 recalls because of the “reasonable probability” that use of the devices could cause serious harm or death.
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