FDA Slaps Class 1 Tag on Medtronic's Capnostream Battery Pack Recall
The FDA today labeled Medtronic‘s (NYSE:MDT) voluntary recall of battery packs used with its Covidien Oridion labeled Capnostream 20 and 20p patient monitors as Class I.
The devices are being recalled due to a defect causing an increased risk of thermal damage in the packs.
Class I recall designations, the agency’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.
The devices are being recalled due to a defect causing an increased risk of thermal damage in the packs.
Class I recall designations, the agency’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.