Class 2 Device Recall TriForce Peripheral Crossing Set

• Date Initiated by Firm: February 01, 2017
• Create Date: March 02, 2017
• Recall Status: Terminated on September 28, 2018
• Recall Number: Z-1393-2017
• Recall Event ID: 76360
• 510(K)Number: K132592
• Product Classification: Catheter, continuous flush - Product Code KRA
• Product: TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch.; The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions. This device is also intended for injection of radiopaque contrast media for the purpose of angiography.
• Code Information: Catalog Identifier: KCXS-5.0- / -RB-0/0-HC KCXS-5.0- / -RB-0/DAV-HC KCXS-5.0- / -RB-MPB/0-HC KCXS-5.0- / -RB-MPB/DAV-HC Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5062454 KCXS-5.0-35-100-RB-0/0-HC 7/8/2014 7/1/2017; 5136679 KCXS-5.0-35-100-RB-0/0-HC 8/7/2014 8/7/2017; 5197803 KCXS-5.0-35-100-RB-0/0-HC 8/21/2014 8/21/2017; 5219620 KCXS-5.0-35-100-RB-0/0-HC 9/2/2014 9/2/2017; 5263513 KCXS-5.0-35-100-RB-0/0-HC 9/18/2014 9/18/2017; 5263513X KCXS-5.0-35-100-RB-0/0-HC 9/18/2014 9/18/2017; 5306527 KCXS-5.0-35-100-RB-0/0-HC 10/9/2014 10/9/2017; 5380279 KCXS-5.0-35-100-RB-0/0-HC 11/3/2014 11/3/2017; 5491296 KCXS-5.0-35-100-RB-0/0-HC 1/7/2015 1/7/2018; 5628924 KCXS-5.0-35-100-RB-0/0-HC 2/27/2015 2/27/2018; 5710455 KCXS-5.0-35-100-RB-0/0-HC 4/14/2015 4/14/2018; 5768551 KCXS-5.0-35-100-RB-0/0-HC 6/9/2015 6/9/2018; 5785293 KCXS-5.0-35-100-RB-0/0-HC 7/7/2015 7/7/2018; 5785296 KCXS-5.0-35-100-RB-0/0-HC 7/7/2015 7/7/2018; 5832319 KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018; 5832319X KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018; 5899897 KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018; 6113669 KCXS-5.0-35-100-RB-0/0-HC 12/2/2015 12/2/2018; 6113672 KCXS-5.0-35-100-RB-0/0-HC 12/2/2015 12/2/2018; NS5216411 KCXS-5.0-35-100-RB-0/0-HC 9/2/2014 9/2/2017; NS5585693 KCXS-5.0-35-100-RB-0/0-HC 2/5/2015 2/5/2018; NS5765432 KCXS-5.0-35-100-RB-0/0-HC 5/26/2015 5/26/2018; NS5968268 KCXS-5.0-35-100-RB-0/0-HC 7/21/2015 7/21/2018; NS6084219 KCXS-5.0-35-100-RB-0/0-HC 8/11/2015 8/11/2018; 5129805 KCXS-5.0-35-100-RB-0/DAV-HC 7/30/2014 7/30/2017; 5248809 KCXS-5.0-35-100-RB-0/DAV-HC 9/12/2014 9/12/2017; 5380252 KCXS-5.0-35-100-RB-0/DAV-HC 11/10/2014 11/10/2017; 5508027 KCXS-5.0-35-100-RB-0/DAV-HC 1/14/2015 1/14/2018; 5628913 KCXS-5.0-35-100-RB-0/DAV-HC 2/27/2015 2/27/2018; 5720805 KCXS-5.0-35-100-RB-0/DAV-HC 7/7/2015 7/7/2018; 5785299 KCXS-5.0-35-100-RB-0/DAV-HC 4/21/2015 4/21/2018; 5785302 KCXS-5.0-35-100-RB-0/DAV-HC 7/7/2015 7/7/2018; 5867734 KCXS-5.0-35-100-RB-0/DAV-HC 7/21/2015 7/21/2018; 5977224 KCXS-5.0-35-100-RB-0/DAV-HC 7/21/2015 7/21/2018; 6113663 KCXS-5.0-35-100-RB-0/DAV-HC 12/2/2015 12/2/2018; 6113666 KCXS-5.0-35-100-RB-0/DAV-HC 12/2/2015 12/2/2018; NS5216405 KCXS-5.0-35-100-RB-0/DAV-HC 9/2/2014 9/2/2017; NS5585699 KCXS-5.0-35-100-RB-0/DAV-HC 2/5/2015 2/5/2018; NS5765435 KCXS-5.0-35-100-RB-0/DAV-HC 5/26/2015 5/26/2018; 5187917 KCXS-5.0-35-100-RB-MPB/0-HC 8/18/2014 8/18/2017; 5380282 KCXS-5.0-35-100-RB-MPB/0-HC 11/10/2014 11/10/2017; 5628927 KCXS-5.0-35-100-RB-MPB/0-HC 2/27/2015 2/27/2018; 5946433 KCXS-5.0-35-100-RB-MPB/0-HC 7/21/2015 7/21/2018; 6117246 KCXS-5.0-35-100-RB-MPB/0-HC 12/6/2015 12/6/2018; 4775656 KCXS-5.0-35-100-RB-MPB/DAV-HC 2014/04 4/1/2017; 5002015 KCXS-5.0-35-100-RB-MPB/DAV-HC 6/1/2014 6/1/2017; 5171189 KCXS-5.0-35-100-RB-MPB/DAV-HC 8/20/2014 8/20/2017; 5350847 KCXS-5.0-35-100-RB-MPB/DAV-HC 10/21/2014 10/21/2017; 5576569 KCXS-5.0-35-100-RB-MPB/DAV-HC 2/2/2015 2/2/2018; 5765330 KCXS-5.0-35-100-RB-MPB/DAV-HC 7/14/2015 7/14/2018; 5889168 KCXS-5.0-35-100-RB-MPB/DAV-HC 7/14/2015 7/14/2018; 6011879 KCXS-5.0-35-100-RB-MPB/DAV-HC 8/5/2015 8/5/2018; 4991593 KCXS-5.0-35-65-RB-0/0-HC 6/1/2014 6/1/2017; 5052389 KCXS-5.0-35-65-RB-0/0-HC 7/3/2014 7/3/2017; 5119567 KCXS-5.0-35-65-RB-0/0-HC 8/4/2014 8/4/2017; 5197734 KCXS-5.0-35-65-RB-0/0-HC 8/21/2014 8/21/2017; 5250866 KCXS-5.0-35-65-RB-0/0-HC 9/12/2014 9/12/2017; 5285973 KCXS-5.0-35-65-RB-0/0-HC 10/2/2014 10/2/2017; 5319450 KCXS-5.0-35-65-RB-0/0-HC 10/23/2014 10/23/2017; 5319450X KCXS-5.0-35-65-RB-0/0-HC 10/23/2014 10/23/2017; 5357710 KCXS-5.0-35-65-RB-0/0-HC 11/3/2014 11/3/2017; 5357710X KCXS-5.0-35-65-RB-0/0-HC 11/3/2014 11/3/2017; 5368594 KCXS-5.0-35-65-RB-0/0-HC 11/3/2014 11/3/2017; 5368594X KCXS-5.0-35-65-RB-0/0-HC 11/3/2014 11/3/2017; 5380184 KCXS-5.0-35-65-RB-0/0-HC 12/2/2014 12/2/2017; 5552476 KCXS-5.0-35-65-RB-0/0-HC 2/11/2015 2/11/2018; 5710423 KCXS-5.0-35-65-RB-0/0-HC 7/7/2015 7/7/2018; 5994612 KCXS-5.0-35-65-RB-0/0-HC 7/23/2015 7/23/2018; 6025639 KCXS-5.0-35-65-RB-0/0-HC 7/27/2015 7/27/2018; 6113657 KCXS-5.0-35-65-RB-0/0-HC 8/25/2015 8/25/2018; 6113660 KCXS-5.0-35-65-RB-0/0-HC 8/25/2015 8/25/2018; 6248448 KCXS-5.0-35-65-RB-0/0-HC 10/18/2015 10/18/2018; 6367139 KCXS-5.0-35-65-RB-0/0-HC 12/1/2015 12/1/2018; NS5216402 KCXS-5.0-35-65-RB-0/0-HC 9/2/2014 9/2/2017; NS5585696 KCXS-5.0-35-65-RB-0/0-HC 2/6/2015 2/6/2018; NS5968265 KCXS-5.0-35-65-RB-0/0-HC 7/21/2015 7/21/2018; 5062379 KCXS-5.0-35-65-RB-0/DAV-HC 7/3/2014 7/3/2017; 5129754 KCXS-5.0-35-65-RB-0/DAV-HC 8/4/2014 8/4/2017; 5214144 KCXS-5.0-35-65-RB-0/DAV-HC 9/3/2014 9/3/2017; 5295076 KCXS-5.0-35-65-RB-0/DAV-HC 10/27/2014 10/27/2017; 5368589 KCXS-5.0-35-65-RB-0/DAV-HC 11/18/2014 11/18/2017; 5459187 KCXS-5.0-35-65-RB-0/DAV-HC 12/8/2014 12/8/2017; 5478599 KCXS-5.0-35-65-RB-0/DAV-HC 12/24/2014 12/24/2017; 5520459 KCXS-5.0-35-65-RB-0/DAV-HC 1/6/2015 1/6/2018; 5529543 KCXS-5.0-35-65-RB-0/DAV-HC 1/30/2015 1/30/2018; 5611132 KCXS-5.0-35-65-RB-0/DAV-HC 2/25/2015 2/25/2018; 5720781 KCXS-5.0-35-65-RB-0/DAV-HC 4/2/2015 4/2/2018; 5733184 KCXS-5.0-35-65-RB-0/DAV-HC 7/14/2015 7/14/2018; 6025630 KCXS-5.0-35-65-RB-0/DAV-HC 7/28/2015 7/28/2018; 6113646 KCXS-5.0-35-65-RB-0/DAV-HC 8/26/2015 8/26/2018; 6113649 KCXS-5.0-35-65-RB-0/DAV-HC 8/25/2015 8/25/2018; 6117201 KCXS-5.0-35-65-RB-0/DAV-HC 8/25/2015 8/25/2018; 6196539 KCXS-5.0-35-65-RB-0/DAV-HC 9/30/2015 9/30/2018; 6386456 KCXS-5.0-35-65-RB-0/DAV-HC 12/6/2015 12/6/2018; NS5216408 KCXS-5.0-35-65-RB-0/DAV-HC 9/2/2014 9/2/2017; NS5615494 KCXS-5.0-35-65-RB-0/DAV-HC 2/11/2015 2/11/2018; NS5700402 KCXS-5.0-35-65-RB-0/DAV-HC 5/26/2015 5/26/2018; NS5739876 KCXS-5.0-35-65-RB-0/DAV-HC 5/26/2015 5/26/2018; NS6061692 KCXS-5.0-35-65-RB-0/DAV-HC 8/4/2015 8/4/2018; NS6084216 KCXS-5.0-35-65-RB-0/DAV-HC 8/20/2015 8/20/2018; 5055952 KCXS-5.0-35-65-RB-MPB/0-HC 7/14/2014 7/14/2017; 5133312 KCXS-5.0-35-65-RB-MPB/0-HC 7/30/2014 7/30/2017; 5295129 KCXS-5.0-35-65-RB-MPB/0-HC 10/27/2014 10/27/2017; 5425112 KCXS-5.0-35-65-RB-MPB/0-HC 12/2/2014 12/2/2017; 5520538 KCXS-5.0-35-65-RB-MPB/0-HC 2/2/2015 2/2/2018; 5648375 KCXS-5.0-35-65-RB-MPB/0-HC 3/6/2015 3/6/2018; 6025674 KCXS-5.0-35-65-RB-MPB/0-HC 7/27/2015 7/27/2018; 6400097 KCXS-5.0-35-65-RB-MPB/0-HC 12/6/2015 12/6/2018; 4885405 KCXS-5.0-35-65-RB-MPB/DAV-HC 2014/04 4/1/2017; 4933653 KCXS-5.0-35-65-RB-MPB/DAV-HC 6/1/2014 6/1/2017; 5029723 KCXS-5.0-35-65-RB-MPB/DAV-HC 6/1/2014 6/1/2017; 5285976 KCXS-5.0-35-65-RB-MPB/DAV-HC 9/23/2014 9/23/2017; 5335460 KCXS-5.0-35-65-RB-MPB/DAV-HC 10/27/2014 10/27/2017; 5459197 KCXS-5.0-35-65-RB-MPB/DAV-HC 12/12/2014 12/12/2017; 5559626 KCXS-5.0-35-65-RB-MPB/DAV-HC 2/11/2015 2/11/2018; 5675132 KCXS-5.0-35-65-RB-MPB/DAV-HC 7/9/2015 7/9/2018; 5751907 KCXS-5.0-35-65-RB-MPB/DAV-HC 7/14/2015 7/14/2018; 5822250 KCXS-5.0-35-65-RB-MPB/DAV-HC 7/14/2015 7/14/2018; 5849197 KCXS-5.0-35-65-RB-MPB/DAV-HC 7/14/2015 7/14/2018; 5867761 KCXS-5.0-35-65-RB-MPB/DAV-HC 7/14/2015 7/14/2018; 6041089 KCXS-5.0-35-65-RB-MPB/DAV-HC 7/29/2015 7/29/2018; 6157884 KCXS-5.0-35-65-RB-MPB/DAV-HC 9/9/2015 9/9/2018; 6212399 KCXS-5.0-35-65-RB-MPB/DAV-HC 9/30/2015 9/30/2018; 6280093 KCXS-5.0-35-65-RB-MPB/DAV-HC 10/29/2015 10/29/2018; 6362463 KCXS-5.0-35-65-RB-MPB/DAV-HC 11/20/2015 11/20/2018.
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Departme; 812-339-2235
• Manufacturer Reason for Recall: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
• FDA Determined Cause: Under Investigation by firm
• Action: Cook Inc. is initiating a voluntary recall of multiple products following the identification of an increase in reports of blood loss associated with devices using a specific hemostatic valve design referred to as the blue valve or polyisoprene valve. Potential adverse events that may occur if these devices were used in the arterial system (Flexor Radial Access Sets) include delay in procedure and blood loss. If devices were used in the central venous system, adverse events that may occur include delay in procedure, blood loss, or air embolism. The firm is distributing notices via mail courier on 02/01/2017. Customers are being instructed to share the recall notice with appropriate personnel, including down to the user level, within the customer's organization or to any organization where the potentially affected devices have been transferred. 1. Examine inventory immediately to determine if customers have affected product and quarantine affected product(s). 2. Return affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Returned un-affected product will not be credited. 3. Even if customers do not have affected product on hand, customers must still complete the Acknowledgement and Receipt Form and return via fax 812.339.7316 or email to Fieldactionsna@cookmedical.com. 4. Report adverse events to COOK Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email to: customerrelationsna@cookmedical.com. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 Effectiveness checks of this recall will be done by response form mailed. All recalled products will be destroyed at the regional distribution warehouses. A cer
• Quantity in Commerce: 1,875
• Distribution: Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Armenia, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Spain, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kenya, Kuwait, Lithuania, Mauritius, Netherlands, Norway, Oman, Poland, Reunion, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom VA/DOD: Yes
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KRA and Original Applicant = COOK, INC.