Home / Recalls / Cook Inc. / Z-1387-2017

Z-1387-2017 Class II Terminated

Recalled by Cook Inc. — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
March 8, 2017
Initiation Date
February 1, 2017
Termination Date
September 28, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
884

Product Description

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.

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.

Distribution Pattern

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

Code Information

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

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