Class I Recall For Cook Medical Guide Wire
The US FDA gave its highest risk designation to Cook’s recall of its Fixed Core Wire Guide.
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The company has yanked from the market more than 37,000 of its catheters because there’s a chance they can break apart.
The recall of the kit, which is part of the HeartWare HVAD System, was affixed with the US agency’s highest risk classification on 1 March.
It’s yet another internal deadline missed by the US agency in publishing a draft of its overhauled Quality System Regulation, which is being harmonized with international quality systems standard ISO 13485.