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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1393-2017

TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions. This device is also intended for injection of radiopaque contrast media for the purpose of angiography.

Publicado el 8 de marzo de 2017 · Inicio del retiro: 1 de febrero de 2017

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Cook Inc.
Distribuidor
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
Lote
Catalog Identifier: KCXS-5.0- / -RB-0/0-HC KCXS-5.0- / -RB-0/DAV-HC KCXS-5.0- / -RB-MPB/0-HC KCXS-5.0- / -RB-MPB/DAV-HC Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5062454 KCXS-5.0-35-100-RB-0/0-HC 7/8/2014 7/1/2017; 5136679 KCXS-5.0-35-100-RB-0/0-HC 8/7/2014 8/7/2017; 5197803 KCXS-5.0-35-100-RB-0/0-HC 8/21/2014 8/21/2017; 5219620 KCXS-5.0-35-100-RB-0/0-HC 9/2/2014 9/2/2017; 5263513 KCXS-5.0-35-100-RB-0/0-HC 9/18/2014 9/18/2017; 5263513X KCXS-5.0-35-100-RB-0/0-HC 9/18/2014 9/18/2017; 5306527 KCXS-5.0-35-100-RB-0/0-HC 10/9/2014 10/9/2017; 5380279 KCXS-5.0-35-100-RB-0/0-HC 11/3/2014 11/3/2017; 5491296 KCXS-5.0-35-100-RB-0/0-HC 1/7/2015 1/7/2018; 5628924 KCXS-5.0-35-100-RB-0/0-HC 2/27/2015 2/27/2018; 5710455 KCXS-5.0-35-100-RB-0/0-HC 4/14/2015 4/14/2018; 5768551 KCXS-5.0-35-100-RB-0/0-HC 6/9/2015 6/9/2018; 5785293 KCXS-5.0-35-100-RB-0/0-HC 7/7/2015 7/7/2018; 5785296 KCXS-5.0-35-100-RB-0/0-HC 7/7/2015 7/7/2018; 5832319 KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018; 5832319X KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018; 5899897 KCXS-5.0-35-100-RB-0/0-HC 7/10/2015 7/10/2018; 6113669 KCXS-5.0-35-100-RB-0/0-HC 12/2/2015 12/2/2018; 6113672 KCXS-5.0-35-100-RB-0/0-HC 12/2/2015 12/2/2018; NS5216411 KCXS-5.0-35-100-RB-0/0-HC 9/2/2014 9/2/2017; NS5585693 KCXS-5.0-35-100-RB-0/0-HC 2/5/2015 2/5/2018; NS5765432 KCXS-5.0-35-100-RB-0/0-HC 5/26/2015 5/26/2018; NS5968268 KCXS-5.0-35-100-RB-0/0-HC 7/21/2015 7/21/2018; NS6084219 KCXS-5.0-35-100-RB-0/0-HC 8/11/2015 8/11/2018; 5129805 KCXS-5.0-35-100-RB-0/DAV-HC 7/30/2014 7/30/2017; 5248809 KCXS-5.0-35-100-RB-0/DAV-HC 9/12/2014 9/12/2017; 5380252 KCXS-5.0-35-100-RB-0/DAV-HC 11/10/2014 11/10/2017; 5508027 KCXS-5.0-35-100-RB-0/DAV-HC 1/14/2015 1/14/2018; 5628913 KCXS-5.0-35-100-RB-0/DAV-HC 2/27/2015 2/27/2018; 5720805 KCXS-5.0-35-100-RB-0/DAV-HC 7/7/2015 7/7/2018; 5785299 KCXS-5.0-35-100-RB-0/DAV-HC 4/21/2015 4/21/2018; 5785302 KCXS-5.0-35-100-RB-0/DAV-HC 7/7/2015 7/7/2018; 5867734 KCXS-5.0-35-100-RB-0/DAV-HC 7/21/2015 7/21/2018; 5977224 KCXS-5.0-35-100-RB-0/DAV-HC 7/21/2015 7/21/2018; 6113663 KCXS-5.0-35-100-RB-0/DAV-HC 12/2/2015 12/2/2018; 6113666 KCXS-5.0-35-100-RB-0/DAV-HC 12/2/2015 12/2/2018; NS5216405 KCXS-5.0-35-100-RB-0/DAV-HC 9/2/2014 9/2/2017; NS5585699 KCXS-5.0-35-100-RB-0/DAV-HC 2/5/2015 2/5/2018; NS5765435 KCXS-5.0-35-100-RB-0/DAV-HC 5/26/2015 5/26/2018; 5187917 KCXS-5.0-35-100-RB-MPB/0-HC 8/18/2014 8/18/2017; 5380282 KCXS-5.0-35-100-RB-MPB/0-HC 11/10/2014 11/10/2017; 5628927 KCXS-5.0-35-100-RB-MPB/0-HC 2/27/2015 2/27/2018; 5946433 KCXS-5.0-35-100-RB-MPB/0-HC 7/21/2015 7/21/2018; 6117246 KCXS-5.0-35-100-RB-MPB/0-HC 12/6/2015 12/6/2018; 4775656 KCXS-5.0-35-100-RB-MPB/DAV-HC 2014/04 4/1/2017; 5002015 KCXS-5.0-35-100-RB-MPB/DAV-HC 6/1/2014 6/1/2017; 5171189 KCXS-5.0-35-100-RB-MPB/DAV-HC 8/20/2014 8/20/2017; 5350847 KCXS-5.0-35-100-RB-MPB/DAV-HC 10/21/2014 10/21/2017; 5576569 KCXS-5.0-35-100-RB-MPB/DAV-HC 2/2/2015 2/2/2018; 5765330 KCXS-5.0-35-100-RB-MPB/DAV-HC 7/14/2015 7/14/2018; 5889168 KCXS-5.0-35-100-RB-MPB/DAV-HC 7/14/2015 7/14/2018; 6011879 KCXS-5.0-35-100-RB-MPB/DAV-HC 8/5/2015 8/5/2018; 4991593 KCXS-5.0-35-65-RB-0/0-HC 6/1/2014 6/1/2017; 5052389 KCXS-5.0-35-65-RB-0/0-HC 7/3/2014 7/3/2017; 5119567 KCXS-5.0-35-65-RB-0/0-HC 8/4/2014 8/4/2017; 5197734 KCXS-5.0-35-65-RB-0/0-HC 8/21/2014 8/21/2017; 5250866 KCXS-5.0-35-65-RB-0/0-HC 9/12/2014 9/12/2017; 5285973 KCXS-5.0-35-65-RB-0/0-HC 10/2/2014 10/2/2017; 5319450 KCXS-5.0-35-65-RB-0/0-HC 10/23/2014 10/23/2017; 5319450X KCXS-5.0-35-65-RB-0/0-HC 10/23/2014 10/23/2017; 5357710 KCXS-5.0-35-65-RB-0/0-HC 11/3/2014 11/3/2017; 5357710X KCXS-5.0-35-65-RB-0/0-HC 11/3/2014 11/3/2017; 5368594 KCXS-5.0-35-65-RB-0/0-HC 11/3/2014 11/3/2017; 5368594X KCXS-5.0-35-65-RB-0/0-HC 11/3/2014 11/3/2017; 5380184 KCXS-5.0-35-65-RB-0/0-HC 12/2/2014 12/2/2017; 5552476 KCXS-5.0-35-65-RB-0/0-HC 2/11/2015 2/11/2018; 5710423 KCXS-5.0-35-65-RB-0/0-HC 7/7/2015 7/7/2018; 59946
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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