Products have been shown to split or separate at the tip
October 13, 2015
Cook Medical is recalling select sizes of Beacon® Tip Angiographic Catheters, an expansion of a voluntary lot-specific recall issued on July 2, 2015.
The products include specific versions of the Torcon NB® Advantage Beacon®Tip Catheters (catalog prefix HNBR4.0, HNBR4.1 and only HNBR5.0 with the RUC suffix), Royal Flush® Plus Beacon®Tip High-Flow Catheters (catalog prefix HNR4.0), Slip-Cath® Beacon® Tip Hydrophilic Catheters (catalog prefix SCBR4.0, SCBR4.1, and only SCBR5.0 with the RUC suffix), and Shuttle®Select Slip-Cath® catheters (catalog prefix SCBR4.5).
These products have been found to split or separate at the tip, which can lead to loss of function in the devices and potential medical hazards. If the tip completely separates from the device, then it may need to be medically retrieved in order to prevent blood from flowing to end organs.
The products included in this recall were distributed globally within a three-year period -- between September of 2012 and September of 2015. Products can be identified by the part number on the outer package product label.
The company has notified the Federal Drug Administration, distributors, and customers by sending notification letters. Any consumers using these products are asked to discontinue use of all affected units and return the products to the company as soon as possible for credit.
If you have any questions or concerns, you can contact Cook Medical Customer Relations, Monday through Friday, at 1-800-457-4500 or 1-812-339-2235 between 7:30 a.m. and 5:00 p.m. ET. You can also email them at CustomerRelationsNA@cookmedical.com.