FDA has designated Cook Medical‘s recall of its Flexor Check-Flo introducers and Flexor tuohy-borst side-arm introducers as Class I, its most serious level.
Cook Medical initiated the recall on Nov. 24. It involves 37,326 of the devices, which are used to deliver medical devices to blood vessels (though not vessels of the heart and brain). The Flexor devices involved in the recall have an increased chance of separating at a specific point, the proximal bond site, FDA said last week in its announcement of the Class I designation.
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