medical Class II Updated 2017-03-08

Cook Inc. recalls Micropuncture Check-Flo Performer Introducer Set, Individual

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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
Lot/Code Info: 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.
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