Cook Medical is recalling 408,011 of its Beacon Tip Catheter in U.S. markets, due to complaints that the catheter tip may split or separate and could potentially enter the patient’s bloodstream.
The recall, designated as Class 1 by the FDA, was initiated Oct. 9, 2014 as an expansion of an original recall in July 2015, according to an agency notice posted Feb. 25.
The recall involves the Torcon NB Advantage Beacon Tip Catheters, Royal Flush Plus Beacon Tip High-Flow Catheters, Slip-Cath Beacon Tip Hydrophilic Catheters and Shuttle Select Slip-Cath Catheters.
The products were manufactured from Aug. 10, 2012 to Sept. 10, 2015 and distributed from Sept. 12, 2012 to Sept. 22, 2015.
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