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.