Cook Inc. recalls Check-Flo Performer Introducer Set, Individual product is pa

Hazard / Issue

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.

Issued by

FDA

Affected States: 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

Lot/Code Info: Catalog Identifier:RCF-4.0(5.0,6.0,7.0,8.0)- / -BV Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4860671 RCF-4.0-35-J-BV 2014/03 3/1/2017; 5018663 RCF-4.0-35-J-BV 6/1/2014 6/1/2017; 5152571 RCF-4.0-35-J-BV 8/5/2014 8/5/2017; 5219529 RCF-4.0-35-J-BV 9/4/2014 9/4/2017; 5475523 RCF-4.0-35-J-BV 12/9/2014 12/9/2017; 6125807 RCF-4.0-35-J-BV 9/8/2015 9/8/2018; NS5210596 RCF-4.0-35-J-BV 8/27/2014 8/27/2017; 4790887 RCF-5.0-35-J-BV 2014/02 2/1/2017; 4879368 RCF-5.0-35-J-BV 2014/04 4/1/2017; 4995370 RCF-5.0-35-J-BV 5/1/2014 5/1/2017; 5018661 RCF-5.0-35-J-BV 6/1/2014 6/1/2017; 5105572 RCF-5.0-35-J-BV 7/31/2014 7/31/2017; 5191953 RCF-5.0-35-J-BV 8/14/2014 8/14/2017; 5230090 RCF-5.0-35-J-BV 9/4/2014 9/4/2017; 5335405 RCF-5.0-35-J-BV 10/22/2014 10/22/2017; 5391106 RCF-5.0-35-J-BV 11/18/2014 11/18/2017; 5550365 RCF-5.0-35-J-BV 2/3/2015 2/3/2018; 5632266 RCF-5.0-35-J-BV 3/3/2015 3/3/2018; 5825763 RCF-5.0-35-J-BV 5/8/2015 5/8/2018; NS6041240 RCF-5.0-35-J-BV 8/6/2015 8/6/2018; 4800069 RCF-6.0-35-J-BV 2014/02 2/1/2017; 4938694 RCF-6.0-35-J-BV 2014/05 5/1/2017; 4995361 RCF-6.0-35-J-BV 6/1/2014 6/1/2017; 5026341 RCF-6.0-35-J-BV 6/1/2014 6/1/2017; 5105539 RCF-6.0-35-J-BV 7/18/2014 7/18/2017; 5115956 RCF-6.0-35-J-BV 7/23/2014 7/23/2017; 5191946 RCF-6.0-35-J-BV 8/15/2014 8/15/2017; 5204970 RCF-6.0-35-J-BV 8/28/2014 8/28/2017; 5237288 RCF-6.0-35-J-BV 9/12/2014 9/12/2017; 5306462 RCF-6.0-35-J-BV 10/3/2014 10/3/2017; 5335304 RCF-6.0-35-J-BV 10/20/2014 10/20/2017; 5589594 RCF-6.0-35-J-BV 2/23/2015 2/23/2018; 5621222 RCF-6.0-35-J-BV 2/24/2015 2/24/2018; 5781933 RCF-6.0-35-J-BV 4/30/2015 4/30/2018; 5839252 RCF-6.0-35-J-BV 5/11/2015 5/11/2018; 5933749 RCF-6.0-35-J-BV 7/10/2015 7/10/2018; 5998390 RCF-6.0-35-J-BV 7/28/2015 7/28/2018; 6145159 RCF-6.0-35-J-BV 9/11/2015 9/11/2018; NS6043629 RCF-6.0-35-J-BV 8/9/2015 8/9/2018; NS6332956 RCF-6.0-35-J-BV 11/17/2015 11/17/2018; 4790871 RCF-7.0-35-J-BV 2014/03 3/1/2017; 5018638 RCF-7.0-35-J-BV 6/1/2014 6/1/2017; 5459181 RCF-7.0-35-J-BV 12/11/2014 12/11/2017; 5600122 RCF-7.0-35-J-BV 2/6/2015 2/6/2018; 5765286 RCF-7.0-35-J-BV 4/20/2015 4/20/2018; 5905965 RCF-7.0-35-J-BV 6/15/2015 6/15/2018; 4729143 RCF-8.0-38-J-BV 2014/01 1/1/2017; 4893493 RCF-8.0-38-J-BV 2014/04 4/1/2017; 5018702 RCF-8.0-38-J-BV 6/1/2014 6/1/2017; 5214240 RCF-8.0-38-J-BV 8/26/2014 8/26/2017; 5429421 RCF-8.0-38-J-BV 11/18/2014 11/18/2017; 5486519 RCF-8.0-38-J-BV 1/6/2015 1/6/2018; 5637340 RCF-8.0-38-J-BV 3/2/2015 3/2/2018; 6073269 RCF-8.0-38-J-BV 8/13/2015 8/13/2018.