FDAnews Device Daily Bulletin

FDA Raises Cook Recall to Class I

Sept. 15, 2016

The FDA has elevated Cook Medical’s global recall of 8,750 units of its Roadrunner UniGlide hydrophilic wire guides as a Class I recall, the most serious type of recall.

Cook Medical announced the recall in August due to the possibility of glass particles in the coating of the wire guide units.

Cook asked customers and distributors to quarantine and discontinue use of all recalled units. — Tamra Sami

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