Image courtesy of Cook Medical
October 14, 2015 — On Oct. 7, 2015, Cook Medical initiated a voluntary recall for select sizes of Beacon Tip Angiographic Catheters. This recall includes all lots of these select sizes of the Beacon Tip Angiographic Catheters. This recall is an expansion of the 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), and 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).
The list of lot numbers affected by the recall can be found here.
The catheters have been found to exhibit tip splitting or separation, which has resulted in 42 Medical Device Reports. Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or, if not retrieved, has the potential to occlude blood flow to end organs.
The Beacon Tip Angiographic Catheters in this recall were distributed globally between September 2012 and September 2015. Product can be identified by the part number provided on the outer package product label. The part numbers for products subject to this recall are those with catalog number prefixes and suffixes listed in the initial paragraph above. All lots currently in distribution are affected.
Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.
The U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world have been notified of this action.
Consumers with questions may contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339- 2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or by email at [email protected]
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
For more information: www.cookmedical.com