Cook Inc.: 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.; 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.

Agency Publication Date: March 2, 2017

Affected Products

Product: Check-Flo Performer Introducer, 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.

Catalog Identifier: RCFW-4.0(5.0,6.0,7.0,8.0)- / -BV Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4826254, RCFW-4.0-35-BV, 2014/03, 3/1/2017; 504036, 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

Product: Check-Flo Performer Introducer Set, 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.

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.

Product: Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

Catalog Identifier: CFM-200 Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5383334 CFM-200 10/22/2014 10/22/2017; 5413859 CFM-200 11/3/2014 11/3/2017; 5534624 CFM-200 12/22/2014 12/22/2017; 5596858 CFM-200 1/21/2015 1/21/2018; 5596860 CFM-200 1/21/2015 1/21/2018; 5658131 CFM-200 2/16/2015 2/16/2018; 5683532 CFM-200 2/27/2015 2/27/2018; 5683534 CFM-200 2/27/2015 2/27/2018; 5687431 CFM-200 3/2/2015 3/2/2018; 5741270 CFM-200 3/23/2015 3/23/2018; 5781086 CFM-200 4/6/2015 4/6/2018; 5831551 CFM-200 4/23/2015 4/23/2018; 5836503 CFM-200 4/27/2015 4/27/2018; 5864629 CFM-200 5/6/2015 5/6/2018; 5918539 CFM-200 5/29/2015 5/29/2018; 5952200 CFM-200 6/11/2015 6/11/2018; 5971838 CFM-200 6/19/2015 6/19/2018; 6072470 CFM-200 7/28/2015 7/28/2018; 6072479 CFM-200 7/28/2015 7/28/2018; 6165074 CFM-200 8/29/2015 8/29/2018; 6223829 CFM-200 9/22/2015 9/22/2018; 6255406 CFM-200 10/2/2015 10/2/2018; 6255407 CFM-200 10/2/2015 10/2/2018; 6255408 CFM-200 10/2/2015 10/2/2018; 6276169 CFM-200 10/12/2015 10/12/2018; 6278920 CFM-200 10/12/2015 10/12/2018; 6311713 CFM-200 10/23/2015 10/23/2018; 6332089 CFM-200 10/29/2015 10/29/2018; 6360092 CFM-200 11/6/2015 11/6/2018; NS5226487 CFM-200 8/20/2014 8/20/2017; NS5514147 CFM-200 12/12/2014 12/12/2017; NS5658130 CFM-200 2/16/2015 2/16/2018; NS5712801 CFM-200 3/11/2015 3/11/2018; NS5759898 CFM-200 3/30/2015 3/30/2018; NS5864632 CFM-200 5/6/2015 5/6/2018; NS5871863 CFM-200 5/11/2015 5/11/2018; NS5945483 CFM-200 6/9/2015 6/9/2018; NS6091885 CFM-200 8/4/2015 8/4/2018; NS6126832 CFM-200 8/17/2015 8/17/2018; NS6147094 CFM-200 8/24/2015 8/24/2018; NS6360093 CFM-200 11/6/2015 11/6/2018.

Product: Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

Catalog Identifier: KCFN-4.0(5.0,6.0,7.0)- / -RA-(S)-HC Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4427564X KCFN-4.0-18-13-RA-HC 8/21/2014 8/21/2017 4427564XX KCFN-4.0-18-13-RA-HC 8/21/2014 8/21/2017 4427564XXX KCFN-4.0-18-13-RA-HC 8/21/2014 8/21/2017 4427566X KCFN-4.0-18-13-RA-HC 2014/03 3/1/2017 4427568X KCFN-4.0-18-13-RA-HC 2014/03 3/1/2017 4610803X KCFN-4.0-18-13-RA-HC 2014/03 3/1/2017 4954615 KCFN-4.0-18-13-RA-HC 6/1/2014 6/1/2017 5087583 KCFN-4.0-18-13-RA-HC 8/1/2014 8/1/2017 5087583X KCFN-4.0-18-13-RA-HC 8/1/2014 8/1/2017 5102705 KCFN-4.0-18-13-RA-HC 8/11/2014 8/11/2017 5102705X KCFN-4.0-18-13-RA-HC 8/11/2014 8/11/2017 5260392 KCFN-4.0-18-13-RA-HC 10/6/2014 10/6/2017 5260392X KCFN-4.0-18-13-RA-HC 10/6/2014 10/6/2017 4427454X KCFN-4.0-18-23-RA-HC 8/21/2014 8/21/2017 4427454XX KCFN-4.0-18-23-RA-HC 8/21/2014 8/21/2017 4427456X KCFN-4.0-18-23-RA-HC 2014/03 3/1/2017 4427458X KCFN-4.0-18-23-RA-HC 2014/03 3/1/2017 4667209X KCFN-4.0-18-23-RA-HC 8/5/2014 8/5/2017 4844427 KCFN-4.0-18-23-RA-HC 2014/04 4/1/2017 4900689 KCFN-4.0-18-23-RA-HC 5/1/2014 5/1/2017 5579987 KCFN-4.0-18-23-RA-HC 2/25/2015 2/25/2018 4427654X KCFN-4.0-18-7-RA-HC 8/8/2014 8/8/2017 4427656X KCFN-4.0-18-7-RA-HC 2014/03 3/1/2017 4667251X KCFN-4.0-18-7-RA-HC 8/5/2014 8/5/2017 4767849 KCFN-4.0-18-7-RA-HC 2014/03 3/1/2017 5122477 KCFN-4.0-18-7-RA-HC 8/8/2014 8/8/2017 5167205 KCFN-4.0-18-7-RA-HC 8/29/2014 8/29/2017 5167205X KCFN-4.0-18-7-RA-HC 8/29/2014 8/29/2017 5537258 KCFN-4.0-18-7-RA-HC 2/10/2015 2/10/2018 5580037 KCFN-4.0-18-7-RA-HC 2/10/2015 2/10/2018 5628941 KCFN-4.0-18-7-RA-HC 3/16/2015 3/16/2018 5688179 KCFN-4.0-18-7-RA-HC 4/9/2015 4/9/2018 5797339 KCFN-4.0-18-7-RA-HC 5/1/2015 5/1/2018 5956253 KCFN-4.0-18-7-RA-HC 7/14/2015 7/14/2018 6101759 KCFN-4.0-18-7-RA-HC 9/4/2015 9/4/2018 6183817 KCFN-4.0-18-7-RA-HC 10/1/2015 10/1/2018 6273554 KCFN-4.0-18-7-RA-HC 11/8/2015 11/8/2018 6351813 KCFN-4.0-18-7-RA-HC 12/11/2015 12/11/2018 4427728X KCFN-5.0-18-13-RA-HC 8/21/2014 8/21/2017 4427728XX KCFN-5.0-18-13-RA-HC 8/21/2014 8/21/2017 4427728XXX KCFN-5.0-18-13-RA-HC 8/21/2014 8/21/2017 4427730X KCFN-5.0-18-13-RA-HC 8/21/2014 8/21/2017 4427730XX KCFN-5.0-18-13-RA-HC 8/21/2014 8/21/2017 4427732X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427734X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427736X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427738X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427740X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427744X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427746X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427748X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427750X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427752X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427754X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427756X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427758X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427760X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427762X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427764X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427766X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427768X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427770X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427772X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427774X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427776X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4667336X KCFN-5.0-18-13-RA-HC 8/5/2014 8/5/2017 4846949 KCFN-5.0-18-13-RA-HC 2014/04 4/1/2017 4846951 KCFN-5.0-18-13-RA-HC 2014/04 4/1/2017 4846953 KCFN-5.0-18-13-RA-HC 2014/04 4/1/2017 4933698 KCFN-5.0-18-13-RA-HC 5/1/2014 5/1/2017 4933700 KCFN-5.0-18-13-RA-HC 6/1/2014 6/1/2017 4933702 KCFN-5.0-18-13-RA-HC 6/1/2014 6/1/2017 5034189 KCFN-5.0-18-13-RA-HC 7/14/2014 7/14/2017 5034191 KCFN-5.0-18-13-RA-HC 7/16/2014 7/16/2017 5034193 KCFN-5.0-18-13-RA-HC 7/14/2014 7/14/2017 5034195 KCFN-5.0-18-13-RA-HC 7/21/2014 7/21/2017 5102745 KCFN-5.0-18-13-RA-HC 7/21/2014 7/21/2017 5102745X KCFN-5.0-18-13-RA-HC 7/21/2014 7/21/2017 5112123 KCFN-5.0-18-13-RA-HC 8/8/2014 8/8/2017 5112125 KCFN-5.0-18-13-RA-HC 8/8/2014 8/8/2017 5112127 KCFN-5.0-18-13-RA-HC 8/15/2014 8/15/2017 5167398 KCFN-5.0-18-13-RA-HC 8/29/2014 8/29/2017 5167400 KCFN-5.0-18-13-RA-HC 8/29/2014 8/29/2017 5167402 KCFN-5.0-18-13-RA-HC 8/29/2014 8/29/2017 5167404 KCFN-5.0-18-13-RA-HC 9/5/2014 9/5/2017 5167406 KCFN-5.0-18-13-RA-HC 9/5/2014 9/5/2017 5224131 KCFN-5.0-18-13-RA-HC 9/5/2014 9/5/2017 5224133 KCFN-5.0-18-13-RA-HC 9/15/2014 9/15/2017 5224135 KCFN-5.0-18-13-RA-HC 9/18/2014 9/18/2017 5253913 KCFN-5.0-18-13-RA-HC 10/20/2014 10/20/2017 5253915 KCFN-5.0-18-13-RA-HC 10/14/2014 10/14/2017 5253917 KCFN-5.0-18-13-RA-HC 10/20/2014 10/20/2017 5253919 KCFN-5.0-18-13-RA-HC 10/31/2014 10/31/2017 5425165 KCFN-5.0-18-13-RA-HC 12/9/2014 12/9/2017 5425167 KCFN-5.0-18-13-RA-HC 12/16/2014 12/16/2017 5425169 KCFN-5.0-18-13-RA-HC 12/16/2014 12/16/2017 5493731 KCFN-5.0-18-13-RA-HC 1/14/2015 1/14/2018 5493733 KCFN-5.0-18-13-RA-HC 1/27/2015 1/27/2018 5493735 KCFN-5.0-18-13-RA-HC 1/14/2015 1/14/2018 5580062 KCFN-5.0-18-13-RA-HC 2/10/2015 2/10/2018 5589721 KCFN-5.0-18-13-RA-HC 3/18/2015 3/18/2018 5589723 KCFN-5.0-18-13-RA-HC 4/6/2015 4/6/2018 5589725 KCFN-5.0-18-13-RA-HC 4/9/2015 4/9/2018 5651232 KCFN-5.0-18-13-RA-HC 4/9/2015 4/9/2018 5651234 KCFN-5.0-18-13-RA-HC 4/16/2015 4/16/2018 5651236 KCFN-5.0-18-13-RA-HC 4/16/2015 4/16/2018 5651238 KCFN-5.0-18-13-RA-HC 5/1/2015 5/1/2018 5703845 KCFN-5.0-18-13-RA-HC 5/1/2015 5/1/2018 5703847 KCFN-5.0-18-13-RA-HC 5/1/2015 5/1/2018 5703849 KCFN-5.0-18-13-RA-HC 5/18/2015 5/18/2018 5893889 KCFN-5.0-18-13-RA-HC 7/9/2015 7/9/2018 5893891 KCFN-5.0-18-13-RA-HC 7/8/2015 7/8/2018 5971098 KCFN-5.0-18-13-RA-HC 7/29/2015 7/29/2018 5994633 KCFN-5.0-18-13-RA-HC 8/19/2015 8/19/2018 5994635 KCFN-5.0-18-13-RA-HC 8/4/2015 8/4/2018 6025703 KCFN-5.0-18-13-RA-HC 8/4/2015 8/4/2018 6025705 KCFN-5.0-18-13-RA-HC 8/2/2015 8/2/2018 6025707 KCFN-5.0-18-13-RA-HC 8/2/2015 8/2/2018 6117310 KCFN-5.0-18-13-RA-HC 9/10/2015 9/10/2018 6117312 KCFN-5.0-18-13-RA-HC 9/17/2015 9/17/2018 6176097 KCFN-5.0-18-13-RA-HC 9/27/2015 9/27/2018 6176099 KCFN-5.0-18-13-RA-HC 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9/15/2017 5585602 KCFN-6.0-18-7-RA-HC 2/10/2015 2/10/2018 5700318 KCFN-6.0-18-7-RA-HC 5/1/2015 5/1/2018 5842464 KCFN-6.0-18-7-RA-HC 6/19/2015 6/19/2018 NS6035989 KCFN-6.0-18-7-RA-HC 8/18/2015 8/18/2018 4427452X KCFN-7.0-18-13-RA-HC 8/21/2014 8/21/2017 4427452XX KCFN-7.0-18-13-RA-HC 8/21/2014 8/21/2017 4667207X KCFN-7.0-18-13-RA-HC 8/5/2014 8/5/2017 4893510 KCFN-7.0-18-13-RA-HC 2014/05 5/1/2017 4893512 KCFN-7.0-18-13-RA-HC 2014/04 4/1/2017 5143024 KCFN-7.0-18-13-RA-HC 8/15/2014 8/15/2017 5529606 KCFN-7.0-18-13-RA-HC 1/27/2015 1/27/2018 5566469 KCFN-7.0-18-13-RA-HC 2/25/2015 2/25/2018 5579985 KCFN-7.0-18-13-RA-HC 2/10/2015 2/10/2018 5634985 KCFN-7.0-18-13-RA-HC 5/1/2015 5/1/2018 5644741 KCFN-7.0-18-13-RA-HC 5/1/2015 5/1/2018 5675202 KCFN-7.0-18-13-RA-HC 5/1/2015 5/1/2018 5855292 KCFN-7.0-18-13-RA-HC 7/14/2015 7/14/2018 6205756 KCFN-7.0-18-13-RA-HC 10/2/2015 10/2/2018 4427782X KCFN-7.0-18-23-RA-HC 8/21/2014 8/21/2017 4427784X KCFN-7.0-18-23-RA-HC 2014/03 3/1/2017 4427786X KCFN-7.0-18-23-RA-HC 8/6/2014 8/6/2017 4556159X KCFN-7.0-18-23-RA-HC 2014/03 3/1/2017 4667354X KCFN-7.0-18-23-RA-HC 8/5/2014 8/5/2017 4814134 KCFN-7.0-18-23-RA-HC 2014/03 3/1/2017 4905684 KCFN-7.0-18-23-RA-HC 5/1/2014 5/1/2017 5126734 KCFN-7.0-18-23-RA-HC 8/1/2014 8/1/2017 5147561 KCFN-7.0-18-23-RA-HC 8/28/2014 8/28/2017 5156356 KCFN-7.0-18-23-RA-HC 8/28/2014 8/28/2017 5306553 KCFN-7.0-18-23-RA-HC 10/14/2014 10/14/2017 5316191 KCFN-7.0-18-23-RA-HC 11/10/2014 11/10/2017 5354346 KCFN-7.0-18-23-RA-HC 11/6/2014 11/6/2017 5493761 KCFN-7.0-18-23-RA-HC 1/13/2015 1/13/2018 5562614 KCFN-7.0-18-23-RA-HC 2/10/2015 2/10/2018 5585643 KCFN-7.0-18-23-RA-HC 3/16/2015 3/16/2018 5641608 KCFN-7.0-18-23-RA-HC 3/16/2015 3/16/2018 5641610 KCFN-7.0-18-23-RA-HC 3/16/2015 3/16/2018 5644799 KCFN-7.0-18-23-RA-HC 5/18/2015 5/18/2018 5682869 KCFN-7.0-18-23-RA-HC 5/18/2015 5/18/2018 5684511 KCFN-7.0-18-23-RA-HC 2/28/2015 2/28/2018 5842502 KCFN-7.0-18-23-RA-HC 7/14/2015 7/14/2018 6012026 KCFN-7.0-18-23-RA-HC 8/4/2015 8/4/2018 6188966 KCFN-7.0-18-23-RA-HC 10/1/2015 10/1/2018 6284401 KCFN-7.0-18-23-RA-HC 11/29/2015 11/29/2018

Product: Micropuncture Check-Flo Performer Introducer Set, 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

Catalog Identifier: RCFN-4.0(5.0,6.0, 7.0)- / -MPIS-NT-BV Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4726168 RCFN-4.0-18-MPIS-NT-BV 2014/01 1/1/2017; 4734774 RCFN-4.0-18-MPIS-NT-BV 2014/01 1/1/2017; 4785752 RCFN-4.0-18-MPIS-NT-BV 2014/02 2/1/2017; 4941369 RCFN-4.0-18-MPIS-NT-BV 2014/05 5/1/2017; 4941371 RCFN-4.0-18-MPIS-NT-BV 5/1/2014 5/1/2017; 4941373 RCFN-4.0-18-MPIS-NT-BV 5/1/2014 5/1/2017; 4951551 RCFN-4.0-18-MPIS-NT-BV 2014/05 5/1/2017; 4951553 RCFN-4.0-18-MPIS-NT-BV 5/1/2014 5/1/2017; 5045963 RCFN-4.0-18-MPIS-NT-BV 6/1/2014 6/1/2017; 5115985 RCFN-4.0-18-MPIS-NT-BV 7/23/2014 7/23/2017; 5115987 RCFN-4.0-18-MPIS-NT-BV 7/30/2014 7/30/2017; 5129780 RCFN-4.0-18-MPIS-NT-BV 7/28/2014 7/28/2017; 5129782 RCFN-4.0-18-MPIS-NT-BV 7/28/2014 7/28/2017; 5201283 RCFN-4.0-18-MPIS-NT-BV 8/28/2014 8/28/2017; 5319456 RCFN-4.0-18-MPIS-NT-BV 10/21/2014 10/21/2017; 5347620 RCFN-4.0-18-MPIS-NT-BV 10/20/2014 10/20/2017; 5347622 RCFN-4.0-18-MPIS-NT-BV 11/6/2014 11/6/2017; 6091299 RCFN-4.0-18-MPIS-NT-BV 8/30/2015 8/30/2018; 6091301 RCFN-4.0-18-MPIS-NT-BV 8/19/2015 8/19/2018; 6091303 RCFN-4.0-18-MPIS-NT-BV 8/21/2015 8/21/2018; 6091305 RCFN-4.0-18-MPIS-NT-BV 8/24/2015 8/24/2018; 6131402 RCFN-4.0-18-MPIS-NT-BV 9/8/2015 9/8/2018; 5045952 RCFN-5.0-18-MPIS-NT-BV 6/1/2014 6/1/2017; 5187958 RCFN-5.0-18-MPIS-NT-BV 8/14/2014 8/14/2017; 5201279 RCFN-5.0-18-MPIS-NT-BV 9/16/2014 9/16/2017; 5237325 RCFN-5.0-18-MPIS-NT-BV 9/4/2014 9/4/2017; 5335434 RCFN-5.0-18-MPIS-NT-BV 10/24/2014 10/24/2017; 5402692 RCFN-5.0-18-MPIS-NT-BV 11/26/2014 11/26/2017; 5573051 RCFN-5.0-18-MPIS-NT-BV 1/28/2015 1/28/2018; 5589611 RCFN-5.0-18-MPIS-NT-BV 2/10/2015 2/10/2018; NS5233872 RCFN-5.0-18-MPIS-NT-BV 9/4/2014 9/4/2017; NS6043627 RCFN-5.0-18-MPIS-NT-BV 8/4/2015 8/4/2018; NS6374382 RCFN-5.0-18-MPIS-NT-BV 11/29/2015 11/29/2018; 4938690 RCFN-6.0-18-MPIS-NT-BV 2014/05 5/1/2017; NS5350917 RCFN-6.0-18-MPIS-NT-BV 10/23/2014 10/23/2017; NS5402799 RCFN-6.0-18-MPIS-NT-BV 11/14/2014 11/14/2017; NS5493803 RCFN-6.0-18-MPIS-NT-BV 12/15/2014 12/15/2017; NS5562644 RCFN-6.0-18-MPIS-NT-BV 1/28/2015 1/28/2018; NS5600298 RCFN-6.0-18-MPIS-NT-BV 2/9/2015 2/9/2018; NS5623993 RCFN-6.0-18-MPIS-NT-BV 2/20/2015 2/20/2018; NS5896499 RCFN-7.0-18-MPIS-NT-BV 6/24/2015 6/24/2018; NS6323151 RCFN-7.0-18-MPIS-NT-BV 11/12/2015 11/12/2018.

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

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.

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.

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.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76360

Status: Resolved

Manufacturer: Cook Inc.

Manufactured In: United States

Units Affected: 7 products (884; 854; 1,589; 41,975; 778; 29; 1,875)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.