FDAFDA · Food and drugs·Recall number Z-1387-2017

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.

Published March 8, 2017 · Recall initiated: February 1, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Cook Inc.
Distributor: 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
Lot: 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
Risk classification: Class II
Area (FDA): device
Country: United States

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