Edwards Lifesciences is recalling 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufactured December 26, 2017, to April 19, 2018 due to incorrect assembly and reversal of the catheter tubes, the FDA announced. The recall was initiated December 21, 2018, according to a post to the FDA website that noted “The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.”
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