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U.S. Department of Health and Human Services

Class 2 Device Recall CheckFlo Performer Introducer Set

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  Class 2 Device Recall CheckFlo Performer Introducer Set see related information
Date Initiated by Firm February 01, 2017
Create Date March 02, 2017
Recall Status1 Terminated 3 on September 28, 2018
Recall Number Z-1388-2017
Recall Event ID 76360
510(K)Number K132592  
Product Classification Introducer, catheter - Product Code DYB
Product 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.
Code Information Catalog Identifier:RCF-4.0(5.0,6.0,7.0,8.0)- / -BV  Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4860671 RCF-4.0-35-J-BV 2014/03 3/1/2017; 5018663 RCF-4.0-35-J-BV 6/1/2014 6/1/2017; 5152571 RCF-4.0-35-J-BV 8/5/2014 8/5/2017; 5219529 RCF-4.0-35-J-BV 9/4/2014 9/4/2017; 5475523 RCF-4.0-35-J-BV 12/9/2014 12/9/2017; 6125807 RCF-4.0-35-J-BV 9/8/2015 9/8/2018; NS5210596 RCF-4.0-35-J-BV 8/27/2014 8/27/2017; 4790887 RCF-5.0-35-J-BV 2014/02 2/1/2017; 4879368 RCF-5.0-35-J-BV 2014/04 4/1/2017; 4995370 RCF-5.0-35-J-BV 5/1/2014 5/1/2017; 5018661 RCF-5.0-35-J-BV 6/1/2014 6/1/2017; 5105572 RCF-5.0-35-J-BV 7/31/2014 7/31/2017; 5191953 RCF-5.0-35-J-BV 8/14/2014 8/14/2017; 5230090 RCF-5.0-35-J-BV 9/4/2014 9/4/2017; 5335405 RCF-5.0-35-J-BV 10/22/2014 10/22/2017; 5391106 RCF-5.0-35-J-BV 11/18/2014 11/18/2017; 5550365 RCF-5.0-35-J-BV 2/3/2015 2/3/2018; 5632266 RCF-5.0-35-J-BV 3/3/2015 3/3/2018; 5825763 RCF-5.0-35-J-BV 5/8/2015 5/8/2018; NS6041240 RCF-5.0-35-J-BV 8/6/2015 8/6/2018; 4800069 RCF-6.0-35-J-BV 2014/02 2/1/2017; 4938694 RCF-6.0-35-J-BV 2014/05 5/1/2017; 4995361 RCF-6.0-35-J-BV 6/1/2014 6/1/2017; 5026341 RCF-6.0-35-J-BV 6/1/2014 6/1/2017; 5105539 RCF-6.0-35-J-BV 7/18/2014 7/18/2017; 5115956 RCF-6.0-35-J-BV 7/23/2014 7/23/2017; 5191946 RCF-6.0-35-J-BV 8/15/2014 8/15/2017; 5204970 RCF-6.0-35-J-BV 8/28/2014 8/28/2017; 5237288 RCF-6.0-35-J-BV 9/12/2014 9/12/2017; 5306462 RCF-6.0-35-J-BV 10/3/2014 10/3/2017; 5335304 RCF-6.0-35-J-BV 10/20/2014 10/20/2017; 5589594 RCF-6.0-35-J-BV 2/23/2015 2/23/2018; 5621222 RCF-6.0-35-J-BV 2/24/2015 2/24/2018; 5781933 RCF-6.0-35-J-BV 4/30/2015 4/30/2018; 5839252 RCF-6.0-35-J-BV 5/11/2015 5/11/2018; 5933749 RCF-6.0-35-J-BV 7/10/2015 7/10/2018; 5998390 RCF-6.0-35-J-BV 7/28/2015 7/28/2018; 6145159 RCF-6.0-35-J-BV 9/11/2015 9/11/2018; NS6043629 RCF-6.0-35-J-BV 8/9/2015 8/9/2018; NS6332956 RCF-6.0-35-J-BV 11/17/2015 11/17/2018; 4790871 RCF-7.0-35-J-BV 2014/03 3/1/2017; 5018638 RCF-7.0-35-J-BV 6/1/2014 6/1/2017; 5459181 RCF-7.0-35-J-BV 12/11/2014 12/11/2017; 5600122 RCF-7.0-35-J-BV 2/6/2015 2/6/2018; 5765286 RCF-7.0-35-J-BV 4/20/2015 4/20/2018; 5905965 RCF-7.0-35-J-BV 6/15/2015 6/15/2018; 4729143 RCF-8.0-38-J-BV 2014/01 1/1/2017; 4893493 RCF-8.0-38-J-BV 2014/04 4/1/2017; 5018702 RCF-8.0-38-J-BV 6/1/2014 6/1/2017; 5214240 RCF-8.0-38-J-BV 8/26/2014 8/26/2017; 5429421 RCF-8.0-38-J-BV 11/18/2014 11/18/2017; 5486519 RCF-8.0-38-J-BV 1/6/2015 1/6/2018; 5637340 RCF-8.0-38-J-BV 3/2/2015 3/2/2018; 6073269 RCF-8.0-38-J-BV 8/13/2015 8/13/2018. 
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Departme
812-339-2235
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 854
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = COOK, INC.
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