FOR IMMEDIATE RELEASE: October 9, 2015
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington, Indiana 47402
812.339.2235
www.cookmedical.com
Purpose of the Press Release:
On October 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 Beacon Tip Angiographic 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 affected products that are subject to this recall can be found here.
The 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 CustomerRelationsNA@cookmedical.com.
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. Complete and submit the report online at www.fda.gov/medwatch/report.htm or via regular mail or fax. Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178. Adverse events may also be reported to 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 CustomerRelationsNA@cookmedical.com.