The recalled products comprise specific versions and lot numbers of the Torcon NB Advantage Beacon Tip Catheters, (Catalog Prefix HNBR5.0), Royal Flush Plus Beacon Tip High-Flow Catheters (Catalog Prefix HNR4.0), and Slip-Cath Beacon Tip Catheters (Catalog Prefix SCBR5.0).
Beacon Tip Angiographic Catheter products were determined to exhibit tip splitting or separation that resulted in adverse events.
The firm said that it has received 26 complaints of catheter-tip splitting or separation and 14 medical device reports so far in which a tip split or separation occurred.
The products, which supplied between June 2013 and June 2015, have been involved in the recall.
Cook Medical has informed about the recall to the FDA and other regulatory agencies.
Established in 1963, the company distributes its medical devices in around 135 countries across the globe.
