| Class 2 Device Recall Flexor Radial Access Set | |
Date Initiated by Firm | February 01, 2017 |
Create Date | March 02, 2017 |
Recall Status1 |
Terminated 3 on September 28, 2018 |
Recall Number | Z-1390-2017 |
Recall Event ID |
76360 |
510(K)Number | K132592 |
Product Classification |
Introducer, catheter - Product Code DYB
|
Product | Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
The Flexor Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures |
Code Information |
Catalog Identifier: KCFN-4.0(5.0,6.0,7.0)- / -RA-(S)-HC Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 4427564X KCFN-4.0-18-13-RA-HC 8/21/2014 8/21/2017 4427564XX KCFN-4.0-18-13-RA-HC 8/21/2014 8/21/2017 4427564XXX KCFN-4.0-18-13-RA-HC 8/21/2014 8/21/2017 4427566X KCFN-4.0-18-13-RA-HC 2014/03 3/1/2017 4427568X KCFN-4.0-18-13-RA-HC 2014/03 3/1/2017 4610803X KCFN-4.0-18-13-RA-HC 2014/03 3/1/2017 4954615 KCFN-4.0-18-13-RA-HC 6/1/2014 6/1/2017 5087583 KCFN-4.0-18-13-RA-HC 8/1/2014 8/1/2017 5087583X KCFN-4.0-18-13-RA-HC 8/1/2014 8/1/2017 5102705 KCFN-4.0-18-13-RA-HC 8/11/2014 8/11/2017 5102705X KCFN-4.0-18-13-RA-HC 8/11/2014 8/11/2017 5260392 KCFN-4.0-18-13-RA-HC 10/6/2014 10/6/2017 5260392X KCFN-4.0-18-13-RA-HC 10/6/2014 10/6/2017 4427454X KCFN-4.0-18-23-RA-HC 8/21/2014 8/21/2017 4427454XX KCFN-4.0-18-23-RA-HC 8/21/2014 8/21/2017 4427456X KCFN-4.0-18-23-RA-HC 2014/03 3/1/2017 4427458X KCFN-4.0-18-23-RA-HC 2014/03 3/1/2017 4667209X KCFN-4.0-18-23-RA-HC 8/5/2014 8/5/2017 4844427 KCFN-4.0-18-23-RA-HC 2014/04 4/1/2017 4900689 KCFN-4.0-18-23-RA-HC 5/1/2014 5/1/2017 5579987 KCFN-4.0-18-23-RA-HC 2/25/2015 2/25/2018 4427654X KCFN-4.0-18-7-RA-HC 8/8/2014 8/8/2017 4427656X KCFN-4.0-18-7-RA-HC 2014/03 3/1/2017 4667251X KCFN-4.0-18-7-RA-HC 8/5/2014 8/5/2017 4767849 KCFN-4.0-18-7-RA-HC 2014/03 3/1/2017 5122477 KCFN-4.0-18-7-RA-HC 8/8/2014 8/8/2017 5167205 KCFN-4.0-18-7-RA-HC 8/29/2014 8/29/2017 5167205X KCFN-4.0-18-7-RA-HC 8/29/2014 8/29/2017 5537258 KCFN-4.0-18-7-RA-HC 2/10/2015 2/10/2018 5580037 KCFN-4.0-18-7-RA-HC 2/10/2015 2/10/2018 5628941 KCFN-4.0-18-7-RA-HC 3/16/2015 3/16/2018 5688179 KCFN-4.0-18-7-RA-HC 4/9/2015 4/9/2018 5797339 KCFN-4.0-18-7-RA-HC 5/1/2015 5/1/2018 5956253 KCFN-4.0-18-7-RA-HC 7/14/2015 7/14/2018 6101759 KCFN-4.0-18-7-RA-HC 9/4/2015 9/4/2018 6183817 KCFN-4.0-18-7-RA-HC 10/1/2015 10/1/2018 6273554 KCFN-4.0-18-7-RA-HC 11/8/2015 11/8/2018 6351813 KCFN-4.0-18-7-RA-HC 12/11/2015 12/11/2018 4427728X KCFN-5.0-18-13-RA-HC 8/21/2014 8/21/2017 4427728XX KCFN-5.0-18-13-RA-HC 8/21/2014 8/21/2017 4427728XXX KCFN-5.0-18-13-RA-HC 8/21/2014 8/21/2017 4427730X KCFN-5.0-18-13-RA-HC 8/21/2014 8/21/2017 4427730XX KCFN-5.0-18-13-RA-HC 8/21/2014 8/21/2017 4427732X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427734X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427736X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427738X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427740X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427744X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427746X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427748X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427750X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427752X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427754X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427756X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427758X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427760X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427762X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427764X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427766X KCFN-5.0-18-13-RA-HC 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3/18/2018 5589723 KCFN-5.0-18-13-RA-HC 4/6/2015 4/6/2018 5589725 KCFN-5.0-18-13-RA-HC 4/9/2015 4/9/2018 5651232 KCFN-5.0-18-13-RA-HC 4/9/2015 4/9/2018 5651234 KCFN-5.0-18-13-RA-HC 4/16/2015 4/16/2018 5651236 KCFN-5.0-18-13-RA-HC 4/16/2015 4/16/2018 5651238 KCFN-5.0-18-13-RA-HC 5/1/2015 5/1/2018 5703845 KCFN-5.0-18-13-RA-HC 5/1/2015 5/1/2018 5703847 KCFN-5.0-18-13-RA-HC 5/1/2015 5/1/2018 5703849 KCFN-5.0-18-13-RA-HC 5/18/2015 5/18/2018 5893889 KCFN-5.0-18-13-RA-HC 7/9/2015 7/9/2018 5893891 KCFN-5.0-18-13-RA-HC 7/8/2015 7/8/2018 5971098 KCFN-5.0-18-13-RA-HC 7/29/2015 7/29/2018 5994633 KCFN-5.0-18-13-RA-HC 8/19/2015 8/19/2018 5994635 KCFN-5.0-18-13-RA-HC 8/4/2015 8/4/2018 6025703 KCFN-5.0-18-13-RA-HC 8/4/2015 8/4/2018 6025705 KCFN-5.0-18-13-RA-HC 8/2/2015 8/2/2018 6025707 KCFN-5.0-18-13-RA-HC 8/2/2015 8/2/2018 6117310 KCFN-5.0-18-13-RA-HC 9/10/2015 9/10/2018 6117312 KCFN-5.0-18-13-RA-HC 9/17/2015 9/17/2018 6176097 KCFN-5.0-18-13-RA-HC 9/27/2015 9/27/2018 6176099 KCFN-5.0-18-13-RA-HC 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KCFN-6.0-18-23-RA-HC 7/31/2015 7/31/2018 6011948 KCFN-6.0-18-23-RA-HC 8/4/2015 8/4/2018 6011950 KCFN-6.0-18-23-RA-HC 8/4/2015 8/4/2018 6011952 KCFN-6.0-18-23-RA-HC 8/2/2015 8/2/2018 6011954 KCFN-6.0-18-23-RA-HC 8/4/2015 8/4/2018 6011956 KCFN-6.0-18-23-RA-HC 8/4/2015 8/4/2018 6011958 KCFN-6.0-18-23-RA-HC 8/18/2015 8/18/2018 6055589 KCFN-6.0-18-23-RA-HC 8/24/2015 8/24/2018 6055591 KCFN-6.0-18-23-RA-HC 8/17/2015 8/17/2018 6055593 KCFN-6.0-18-23-RA-HC 8/18/2015 8/18/2018 6055595 KCFN-6.0-18-23-RA-HC 8/18/2015 8/18/2018 6055597 KCFN-6.0-18-23-RA-HC 8/17/2015 8/17/2018 6055599 KCFN-6.0-18-23-RA-HC 8/30/2015 8/30/2018 6055601 KCFN-6.0-18-23-RA-HC 9/4/2015 9/4/2018 6080971 KCFN-6.0-18-23-RA-HC 9/4/2015 9/4/2018 6080973 KCFN-6.0-18-23-RA-HC 9/4/2015 9/4/2018 6080975 KCFN-6.0-18-23-RA-HC 9/4/2015 9/4/2018 6080977 KCFN-6.0-18-23-RA-HC 9/9/2015 9/9/2018 6080979 KCFN-6.0-18-23-RA-HC 9/9/2015 9/9/2018 6150471 KCFN-6.0-18-23-RA-HC 9/16/2015 9/16/2018 6150473 KCFN-6.0-18-23-RA-HC 9/25/2015 9/25/2018 6150475 KCFN-6.0-18-23-RA-HC 9/9/2015 9/9/2018 6150477 KCFN-6.0-18-23-RA-HC 9/18/2015 9/18/2018 6154447 KCFN-6.0-18-23-RA-HC 9/18/2015 9/18/2018 6154449 KCFN-6.0-18-23-RA-HC 9/18/2015 9/18/2018 6154451 KCFN-6.0-18-23-RA-HC 9/27/2015 9/27/2018 6154451X KCFN-6.0-18-23-RA-HC 9/27/2015 9/27/2018 6154453 KCFN-6.0-18-23-RA-HC 10/2/2015 10/2/2018 6183805 KCFN-6.0-18-23-RA-HC 9/27/2015 9/27/2018 6183807 KCFN-6.0-18-23-RA-HC 10/2/2015 10/2/2018 6183809 KCFN-6.0-18-23-RA-HC 10/4/2015 10/4/2018 6183811 KCFN-6.0-18-23-RA-HC 10/1/2015 10/1/2018 6217250 KCFN-6.0-18-23-RA-HC 10/15/2015 10/15/2018 6217252 KCFN-6.0-18-23-RA-HC 10/15/2015 10/15/2018 6217254 KCFN-6.0-18-23-RA-HC 10/15/2015 10/15/2018 6217256 KCFN-6.0-18-23-RA-HC 10/15/2015 10/15/2018 6217258 KCFN-6.0-18-23-RA-HC 10/15/2015 10/15/2018 6217260 KCFN-6.0-18-23-RA-HC 10/15/2015 10/15/2018 6217262 KCFN-6.0-18-23-RA-HC 11/3/2015 11/3/2018 6266738 KCFN-6.0-18-23-RA-HC 11/8/2015 11/8/2018 6266740 KCFN-6.0-18-23-RA-HC 11/29/2015 11/29/2018 6266742 KCFN-6.0-18-23-RA-HC 11/25/2015 11/25/2018 6266744 KCFN-6.0-18-23-RA-HC 11/29/2015 11/29/2018 6266746 KCFN-6.0-18-23-RA-HC 12/11/2015 12/11/2018 6266746 KCFN-6.0-18-23-RA-HC 12/11/2015 12/11/2018 6266748 KCFN-6.0-18-23-RA-HC 11/25/2015 11/25/2018 6266750 KCFN-6.0-18-23-RA-HC 11/25/2015 11/25/2018 6280152 KCFN-6.0-18-23-RA-HC 11/25/2015 11/25/2018 6280154 KCFN-6.0-18-23-RA-HC 12/9/2015 12/9/2018 6280156 KCFN-6.0-18-23-RA-HC 12/8/2015 12/8/2018 6280156 KCFN-6.0-18-23-RA-HC 12/8/2015 12/8/2018 6280158 KCFN-6.0-18-23-RA-HC 12/8/2015 12/8/2018 6280160 KCFN-6.0-18-23-RA-HC 12/9/2015 12/9/2018 NS5147585 KCFN-6.0-18-23-RA-HC 9/30/2014 9/30/2017 NS5147585 KCFN-6.0-18-23-RA-HC 9/30/2014 9/30/2017 NS5147585 KCFN-6.0-18-23-RA-HC 9/30/2014 9/30/2017 NS5147585 KCFN-6.0-18-23-RA-HC 9/30/2014 9/30/2017 NS5147585 KCFN-6.0-18-23-RA-HC 9/30/2014 9/30/2017 NS5147585 KCFN-6.0-18-23-RA-HC 9/30/2014 9/30/2017 NS5230212 KCFN-6.0-18-23-RA-HC 11/13/2014 11/13/2017 NS5230212 KCFN-6.0-18-23-RA-HC 11/13/2014 11/13/2017 NS5230212 KCFN-6.0-18-23-RA-HC 11/13/2014 11/13/2017 NS5230212 KCFN-6.0-18-23-RA-HC 11/13/2014 11/13/2017 NS6061690 KCFN-6.0-18-23-RA-HC 8/28/2015 8/28/2018 4427660X KCFN-6.0-18-23-RA-S-HC 8/21/2014 8/21/2017 4427662X KCFN-6.0-18-23-RA-S-HC 8/21/2014 8/21/2017 4427662XX KCFN-6.0-18-23-RA-S-HC 8/21/2014 8/21/2017 4427664X KCFN-6.0-18-23-RA-S-HC 2014/03 3/1/2017 4667267X KCFN-6.0-18-23-RA-S-HC 8/5/2014 8/5/2017 4793616 KCFN-6.0-18-23-RA-S-HC 2014/04 4/1/2017 4893580 KCFN-6.0-18-23-RA-S-HC 2014/04 4/1/2017 4905625 KCFN-6.0-18-23-RA-S-HC 6/1/2014 6/1/2017 6025691 KCFN-6.0-18-23-RA-S-HC 8/4/2015 8/4/2018 6025693 KCFN-6.0-18-23-RA-S-HC 7/31/2015 7/31/2018 6041168 KCFN-6.0-18-23-RA-S-HC 8/18/2015 8/18/2018 4427658X KCFN-6.0-18-7-RA-HC 8/21/2014 8/21/2017 4427658XX KCFN-6.0-18-7-RA-HC 8/21/2014 8/21/2017 4893578 KCFN-6.0-18-7-RA-HC 2014/04 4/1/2017 5102732 KCFN-6.0-18-7-RA-HC 7/25/2014 7/25/2017 5102732X KCFN-6.0-18-7-RA-HC 7/25/2014 7/25/2017 5147478 KCFN-6.0-18-7-RA-HC 9/15/2014 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8/4/2015 8/4/2018 6188966 KCFN-7.0-18-23-RA-HC 10/1/2015 10/1/2018 6284401 KCFN-7.0-18-23-RA-HC 11/29/2015 11/29/2018 |
Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
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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 | 41,975 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = DYB
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