Cook Inc.: 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.

Recall number

Z-1387-2017

Recalling firm

Cook Inc.

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.

Status

Terminated

Initiated

2017-02-01

Posted

not on file

Terminated

2018-09-28

Reason

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.

Root cause

Under Investigation by firm

Action

Cook Inc. is initiating a voluntary recall of multiple products following the identification of an increase in reports of blood loss associated with devices using a specific hemostatic valve design referred to as the blue valve or polyisoprene valve. Potential adverse events that may occur if these devices were used in the arterial system (Flexor Radial Access Sets) include delay in procedure and blood loss. If devices were used in the central venous system, adverse events that may occur include delay in procedure, blood loss, or air embolism. The firm is distributing notices via mail courier on 02/01/2017. Customers are being instructed to share the recall notice with appropriate personnel, including down to the user level, within the customer's organization or to any organization where the potentially affected devices have been transferred. 1. Examine inventory immediately to determine if customers have affected product and quarantine affected product(s). 2. Return affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Returned un-affected product will not be credited. 3. Even if customers do not have affected product on hand, customers must still complete the Acknowledgement and Receipt Form and return via fax 812.339.7316 or email to Fieldactionsna@cookmedical.com. 4. Report adverse events to COOK Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email to: customerrelationsna@cookmedical.com. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: Online at: http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail) Call the FDA at: 1-800-FDA-1088 Effectiveness checks of this recall will be done by response form mailed. All recalled products will be destroyed at the regional distribution warehouses. A cer

Quantity

884

Distribution

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, serial or model codes

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

510(k) numbers

["K132592"]

PMA numbers

not on file

Product code

DYB

Firm FEI

1820334

Firm city

Bloomington

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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