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FDA Updates on Getinge/Datascope IABP Recall, Labels as Class I



8/7/2017 9:58:13 AM

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The FDA today updated on Getinge (PINK:GETI B) subsidiaries Datascope and Maquet’s recall of its CS100i, CSO100 and CS300 intra-aortic balloon pumps, initially announced by the company in June, labeling it as a Class I recall.

Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

Read at MassDevice


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