Z-1387-2017 Class II Terminated
FDA device recall Z-1387-2017 was initiated by Cook Inc. on February 1, 2017 and is designated Class II. 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… The recall status is terminated (terminated September 28, 2018). Affected quantity: 884.
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