The recall affects 95,167 devices, according to the company. The catheters involved were distributed between June 2013 and June 2015.
The products include 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). These catheters have been found to exhibit tip splitting or separation, which has resulted in adverse events.
The company said it has received 26 complaints of catheter tip splitting and/or separation, and 15 medical device reports have been filed to date in which a tip split or separation occurred. Cook has requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return them as soon as possible for credit.
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