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U.S. Department of Health and Human Services

Class 2 Device Recall CheckFlo Introducer HausdorfLock Atrial

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  Class 2 Device Recall CheckFlo Introducer HausdorfLock Atrial see related information
Date Initiated by Firm February 01, 2017
Create Date March 02, 2017
Recall Status1 Terminated 3 on September 28, 2018
Recall Number Z-1392-2017
Recall Event ID 76360
510(K)Number K132592  
Product Classification Introducer, catheter - Product Code DYB
Product Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
Code Information Catalog Identifier:RCFW-7.0(8.0)-38-75-RB-HLA-091100-BV  Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4826254 RCFW-4.0-35-BV 2014/03 3/1/2017; 5040369 RCFW-4.0-35-BV 6/1/2014 6/1/2017; 5364287 RCFW-4.0-35-BV 10/15/2014 10/15/2017; 5379911 RCFW-4.0-35-BV 10/21/2014 10/21/2017; 5400933 RCFW-4.0-35-BV 10/29/2014 10/29/2017; 5435105 RCFW-4.0-35-BV 11/11/2014 11/11/2017; 5462040 RCFW-4.0-35-BV 11/20/2014 11/20/2017; 5474624 RCFW-4.0-35-BV 11/25/2014 11/25/2017; NS5424653 RCFW-4.0-35-BV 11/6/2014 11/6/2017; NS5424654 RCFW-4.0-35-BV 11/6/2014 11/6/2017; 5213872 RCFW-5.0-35-BV 8/14/2014 8/14/2017; 5273219 RCFW-5.0-35-BV 9/10/2014 9/10/2017; 5302128 RCFW-5.0-35-BV 9/23/2014 9/23/2017; 5354215 RCFW-5.0-35-BV 10/10/2014 10/10/2017; 5400931 RCFW-5.0-35-BV 10/29/2014 10/29/2017; 5523548 RCFW-5.0-35-BV 12/17/2014 12/17/2017; 5681717 RCFW-5.0-35-BV 2/26/2015 2/26/2018; 5690760 RCFW-5.0-35-BV 3/3/2015 3/3/2018; 5701193 RCFW-5.0-35-BV 3/6/2015 3/6/2018; 6004897 RCFW-5.0-35-BV 7/2/2015 7/2/2018; 5260343 RCFW-6.0-35-BV 9/4/2014 9/4/2017; 5275648 RCFW-6.0-35-BV 9/11/2014 9/11/2017; 5308224 RCFW-6.0-35-BV 9/24/2014 9/24/2017; 5312947 RCFW-6.0-35-BV 9/25/2014 9/25/2017; 5368247 RCFW-6.0-35-BV 10/16/2014 10/16/2017; 5383333 RCFW-6.0-35-BV 10/22/2014 10/22/2017; 5444866 RCFW-6.0-35-BV 11/13/2014 11/13/2017; 5585193 RCFW-6.0-35-BV 1/16/2015 1/16/2018; 5681719 RCFW-6.0-35-BV 2/26/2015 2/26/2018; 5690162 RCFW-6.0-35-BV 3/3/2015 3/3/2018; 5692849 RCFW-6.0-35-BV 3/4/2015 3/4/2018; 5974636 RCFW-6.0-35-BV 6/20/2015 6/20/2018; 4906939 RCFW-7.0-35-BV 2014/04 4/1/2017; 4987018 RCFW-7.0-35-BV 5/1/2014 5/1/2017; 5228810 RCFW-7.0-35-BV 8/21/2014 8/21/2017; 5275669 RCFW-7.0-35-BV 9/11/2014 9/11/2017; 5301927 RCFW-7.0-35-BV 9/22/2014 9/22/2017; 5301930 RCFW-7.0-35-BV 9/22/2014 9/22/2017; 5312948 RCFW-7.0-35-BV 9/25/2014 9/25/2017; NS5831881 RCFW-7.0-38-75-RB-HLA-091100-BV 4/23/2015 4/23/2018; NS5878399 RCFW-7.0-38-75-RB-HLA-091100-BV 5/12/2015 5/12/2018; NS5890383 RCFW-7.0-38-75-RB-HLA-091100-BV 5/18/2015 5/18/2018; NS5922577 RCFW-7.0-38-75-RB-HLA-091100-BV 6/1/2015 6/1/2018; NS6000260 RCFW-7.0-38-75-RB-HLA-091100-BV 6/30/2015 6/30/2018; NS6091893 RCFW-7.0-38-75-RB-HLA-091100-BV 8/4/2015 8/4/2018; NS6264206 RCFW-7.0-38-75-RB-HLA-091100-BV 10/6/2015 10/6/2018; F4845598 RCFW-8.0-35-BV 2014/03 3/1/2017; NS5312949 RCFW-8.0-35-BV 9/25/2014 9/25/2017; NS5596871 RCFW-8.0-35-BV 1/21/2015 1/21/2018; NS5755064 RCFW-8.0-35-BV 3/26/2015 3/26/2018; NS5793423 RCFW-8.0-35-BV 4/9/2015 4/9/2018; NS5831884 RCFW-8.0-38-75-RB-HLA-091100-BV 4/23/2015 4/23/2018; NS5996958 RCFW-8.0-38-75-RB-HLA-091100-BV 6/29/2015 6/29/2018; NS5996959 RCFW-8.0-38-75-RB-HLA-091100-BV 6/29/2015 6/29/2018; NS6002168 RCFW-8.0-38-75-RB-HLA-091100-BV 7/1/2015 7/1/2018; NS6014785 RCFW-8.0-38-75-RB-HLA-091100-BV 7/7/2015 7/7/2018; NS6014786 RCFW-8.0-38-75-RB-HLA-091100-BV 7/7/2015 7/7/2018; NS6022050 RCFW-8.0-38-75-RB-HLA-091100-BV 7/10/2015 7/10/2018; NS6031799 RCFW-8.0-38-75-RB-HLA-091100-BV 7/14/2015 7/14/2018; NS6083872 RCFW-8.0-38-75-RB-HLA-091100-BV 7/31/2015 7/31/2018; NS6091894 RCFW-8.0-38-75-RB-HLA-091100-BV 8/4/2015 8/4/2018; NS6140704 RCFW-8.0-38-75-RB-HLA-091100-BV 8/20/2015 8/20/2018; NS6225353 RCFW-8.0-38-75-RB-HLA-091100-BV 9/22/2015 9/22/2018; NS6295130 RCFW-8.0-38-75-RB-HLA-091100-BV 10/19/2015 10/19/2018; NS6329426 RCFW-8.0-38-75-RB-HLA-091100-BV 10/28/2015 10/28/2018. 
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 2		 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 29
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 = DYB and Original Applicant = COOK, INC.
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