Class I recalls hit several manufacturers
This article was originally published in The Silver Sheet
FDA has classified a string of recent device recalls as Class I, the most serious recall category. They include Edwards Lifesciences' CardioVations EndoClamp Aortic Catheter; Synthes' Synex II Central Body components, used in the Synex II modular vertebral body replacement system; Pointe Scientific's Liquid Glucose Hexokinase Reagent, used in assays to determine the amount of glucose in blood; Centurion Medical's Premie Pack and Full Term Meconium Pack medical kits; and ConvaTec/Unomedical's Manual Pulmonary Resuscitator
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