Events

Retiro De Equipo (Recall) de Device Recall Flexor Radial Access Set

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cook Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    76360
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1390-2017
  • Fecha de inicio del evento
    2017-02-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152969
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Introducer, catheter - Product Code DYB
  • Causa
    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.
  • Acción
    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

Device

Device Recall Flexor Radial Access Set
  • Modelo / Serial
    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 2014/03 3/1/2017 4427768X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427770X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427772X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427774X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4427776X KCFN-5.0-18-13-RA-HC 2014/03 3/1/2017 4667336X KCFN-5.0-18-13-RA-HC 8/5/2014 8/5/2017 4846949 KCFN-5.0-18-13-RA-HC 2014/04 4/1/2017 4846951 KCFN-5.0-18-13-RA-HC 2014/04 4/1/2017 4846953 KCFN-5.0-18-13-RA-HC 2014/04 4/1/2017 4933698 KCFN-5.0-18-13-RA-HC 5/1/2014 5/1/2017 4933700 KCFN-5.0-18-13-RA-HC 6/1/2014 6/1/2017 4933702 KCFN-5.0-18-13-RA-HC 6/1/2014 6/1/2017 5034189 KCFN-5.0-18-13-RA-HC 7/14/2014 7/14/2017 5034191 KCFN-5.0-18-13-RA-HC 7/16/2014 7/16/2017 5034193 KCFN-5.0-18-13-RA-HC 7/14/2014 7/14/2017 5034195 KCFN-5.0-18-13-RA-HC 7/21/2014 7/21/2017 5102745 KCFN-5.0-18-13-RA-HC 7/21/2014 7/21/2017 5102745X KCFN-5.0-18-13-RA-HC 7/21/2014 7/21/2017 5112123 KCFN-5.0-18-13-RA-HC 8/8/2014 8/8/2017 5112125 KCFN-5.0-18-13-RA-HC 8/8/2014 8/8/2017 5112127 KCFN-5.0-18-13-RA-HC 8/15/2014 8/15/2017 5167398 KCFN-5.0-18-13-RA-HC 8/29/2014 8/29/2017 5167400 KCFN-5.0-18-13-RA-HC 8/29/2014 8/29/2017 5167402 KCFN-5.0-18-13-RA-HC 8/29/2014 8/29/2017 5167404 KCFN-5.0-18-13-RA-HC 9/5/2014 9/5/2017 5167406 KCFN-5.0-18-13-RA-HC 9/5/2014 9/5/2017 5224131 KCFN-5.0-18-13-RA-HC 9/5/2014 9/5/2017 5224133 KCFN-5.0-18-13-RA-HC 9/15/2014 9/15/2017 5224135 KCFN-5.0-18-13-RA-HC 9/18/2014 9/18/2017 5253913 KCFN-5.0-18-13-RA-HC 10/20/2014 10/20/2017 5253915 KCFN-5.0-18-13-RA-HC 10/14/2014 10/14/2017 5253917 KCFN-5.0-18-13-RA-HC 10/20/2014 10/20/2017 5253919 KCFN-5.0-18-13-RA-HC 10/31/2014 10/31/2017 5425165 KCFN-5.0-18-13-RA-HC 12/9/2014 12/9/2017 5425167 KCFN-5.0-18-13-RA-HC 12/16/2014 12/16/2017 5425169 KCFN-5.0-18-13-RA-HC 12/16/2014 12/16/2017 5493731 KCFN-5.0-18-13-RA-HC 1/14/2015 1/14/2018 5493733 KCFN-5.0-18-13-RA-HC 1/27/2015 1/27/2018 5493735 KCFN-5.0-18-13-RA-HC 1/14/2015 1/14/2018 5580062 KCFN-5.0-18-13-RA-HC 2/10/2015 2/10/2018 5589721 KCFN-5.0-18-13-RA-HC 3/18/2015 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 10/14/2015 10/14/2018 6192470 KCFN-5.0-18-13-RA-HC 10/2/2015 10/2/2018 6192472 KCFN-5.0-18-13-RA-HC 10/2/2015 10/2/2018 6284394 KCFN-5.0-18-13-RA-HC 12/9/2015 12/9/2018 6284396 KCFN-5.0-18-13-RA-HC 12/9/2015 12/9/2018 4427778X KCFN-5.0-18-13-RA-S-HC 2014/03 3/1/2017 4427780X KCFN-5.0-18-13-RA-S-HC 8/21/2014 8/21/2017 4427780XX KCFN-5.0-18-13-RA-S-HC 8/21/2014 8/21/2017 4667340X KCFN-5.0-18-13-RA-S-HC 8/5/2014 8/5/2017 4893616 KCFN-5.0-18-13-RA-S-HC 2014/04 4/1/2017 4897225 KCFN-5.0-18-13-RA-S-HC 2014/04 4/1/2017 4991650 KCFN-5.0-18-13-RA-S-HC 6/1/2014 6/1/2017 5102747 KCFN-5.0-18-13-RA-S-HC 8/1/2014 8/1/2017 5102747X KCFN-5.0-18-13-RA-S-HC 8/1/2014 8/1/2017 5580064 KCFN-5.0-18-13-RA-S-HC 2/10/2015 2/10/2018 4427680X KCFN-5.0-18-23-RA-HC 8/21/2014 8/21/2017 4427684X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4427686X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4427688X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4427690X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4427692X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4427694X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4427696X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4427696X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4427698X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4427700X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4427702X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4605309X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4605311X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4691483X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4691485X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4691487X KCFN-5.0-18-23-RA-HC 2014/03 3/1/2017 4893601 KCFN-5.0-18-23-RA-HC 2014/04 4/1/2017 4893603 KCFN-5.0-18-23-RA-HC 2014/04 4/1/2017 4893605 KCFN-5.0-18-23-RA-HC 2014/04 4/1/2017 4900715 KCFN-5.0-18-23-RA-HC 2014/04 4/1/2017 4900717 KCFN-5.0-18-23-RA-HC 2014/04 4/1/2017 4900719 KCFN-5.0-18-23-RA-HC 2014/05 5/1/2017 4905653 KCFN-5.0-18-23-RA-HC 6/1/2014 6/1/2017 4905655 KCFN-5.0-18-23-RA-HC 6/1/2014 6/1/2017 4905657 KCFN-5.0-18-23-RA-HC 6/1/2014 6/1/2017 5094891 KCFN-5.0-18-23-RA-HC 8/8/2014 8/8/2017 5094891 KCFN-5.0-18-23-RA-HC 8/8/2014 8/8/2017 5094893 KCFN-5.0-18-23-RA-HC 8/15/2014 8/15/2017 5102736 KCFN-5.0-18-23-RA-HC 7/21/2014 7/21/2017 5102736X KCFN-5.0-18-23-RA-HC 7/21/2014 7/21/2017 5122485 KCFN-5.0-18-23-RA-HC 8/11/2014 8/11/2017 5122487 KCFN-5.0-18-23-RA-HC 8/15/2014 8/15/2017 5122489 KCFN-5.0-18-23-RA-HC 8/28/2014 8/28/2017 5143028 KCFN-5.0-18-23-RA-HC 8/15/2014 8/15/2017 5143030 KCFN-5.0-18-23-RA-HC 8/28/2014 8/28/2017 5171213 KCFN-5.0-18-23-RA-HC 8/28/2014 8/28/2017 5171215 KCFN-5.0-18-23-RA-HC 8/28/2014 8/28/2017 5171217 KCFN-5.0-18-23-RA-HC 9/12/2014 9/12/2017 5253880 KCFN-5.0-18-23-RA-HC 10/6/2014 10/6/2017 5253882 KCFN-5.0-18-23-RA-HC 10/14/2014 10/14/2017 5253884 KCFN-5.0-18-23-RA-HC 10/3/2014 10/3/2017 5263587 KCFN-5.0-18-23-RA-HC 10/20/2014 10/20/2017 5263589 KCFN-5.0-18-23-RA-HC 10/20/2014 10/20/2017 5298730 KCFN-5.0-18-23-RA-HC 10/20/2014 10/20/2017 5298732 KCFN-5.0-18-23-RA-HC 10/14/2014 10/14/2017 5298732 KCFN-5.0-18-23-RA-HC 10/14/2014 10/14/2017 5298734 KCFN-5.0-18-23-RA-HC 10/31/2014 10/31/2017 5364979 KCFN-5.0-18-23-RA-HC 12/15/2014 12/15/2017 5364981 KCFN-5.0-18-23-RA-HC 12/11/2014 12/11/2017 5364983 KCFN-5.0-18-23-RA-HC 12/9/2014 12/9/2017 5421713 KCFN-5.0-18-23-RA-HC 11/25/2014 11/25/2017 5421715 KCFN-5.0-18-23-RA-HC 12/11/2014 12/11/2017 5421717 KCFN-5.0-18-23-RA-HC 12/9/2014 12/9/2017 5520711 KCFN-5.0-18-23-RA-HC 1/27/2015 1/27/2018 5520711X KCFN-5.0-18-23-RA-HC 1/27/2015 1/27/2018 5520713 KCFN-5.0-18-23-RA-HC 1/27/2015 1/27/2018 5600196 KCFN-5.0-18-23-RA-HC 3/16/2015 3/16/2018 5600198 KCFN-5.0-18-23-RA-HC 3/16/2015 3/16/2018 5600200 KCFN-5.0-18-23-RA-HC 4/8/2015 4/8/2018 5675240 KCFN-5.0-18-23-RA-HC 4/22/2015 4/22/2018 5675242 KCFN-5.0-18-23-RA-HC 4/22/2015 4/22/2018 5675244 KCFN-5.0-18-23-RA-HC 5/18/2015 5/18/2018 5839392 KCFN-5.0-18-23-RA-HC 6/17/2015 6/17/2018 5839394 KCFN-5.0-18-23-RA-HC 6/26/2015 6/26/2018 5842468 KCFN-5.0-18-23-RA-HC 6/29/2015 6/29/2018 5842470 KCFN-5.0-18-23-RA-HC 6/24/2015 6/24/2018 6019212 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  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Dirección del fabricante
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Empresa matriz del fabricante (2017)
    Cook Group Incorporated
  • Source
    USFDA