Cook Inc.: 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

Recall number

Z-1391-2017

Recalling firm

Cook Inc.

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

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

778

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: 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.

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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