FDAFDA · Alimentos y medicamentos·N.º oficial Z-1389-2017
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
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: CFM-200 Codes consist of Lot #, RPN #, Manufacture Date and Expiration Date: 5383334 CFM-200 10/22/2014 10/22/2017; 5413859 CFM-200 11/3/2014 11/3/2017; 5534624 CFM-200 12/22/2014 12/22/2017; 5596858 CFM-200 1/21/2015 1/21/2018; 5596860 CFM-200 1/21/2015 1/21/2018; 5658131 CFM-200 2/16/2015 2/16/2018; 5683532 CFM-200 2/27/2015 2/27/2018; 5683534 CFM-200 2/27/2015 2/27/2018; 5687431 CFM-200 3/2/2015 3/2/2018; 5741270 CFM-200 3/23/2015 3/23/2018; 5781086 CFM-200 4/6/2015 4/6/2018; 5831551 CFM-200 4/23/2015 4/23/2018; 5836503 CFM-200 4/27/2015 4/27/2018; 5864629 CFM-200 5/6/2015 5/6/2018; 5918539 CFM-200 5/29/2015 5/29/2018; 5952200 CFM-200 6/11/2015 6/11/2018; 5971838 CFM-200 6/19/2015 6/19/2018; 6072470 CFM-200 7/28/2015 7/28/2018; 6072479 CFM-200 7/28/2015 7/28/2018; 6165074 CFM-200 8/29/2015 8/29/2018; 6223829 CFM-200 9/22/2015 9/22/2018; 6255406 CFM-200 10/2/2015 10/2/2018; 6255407 CFM-200 10/2/2015 10/2/2018; 6255408 CFM-200 10/2/2015 10/2/2018; 6276169 CFM-200 10/12/2015 10/12/2018; 6278920 CFM-200 10/12/2015 10/12/2018; 6311713 CFM-200 10/23/2015 10/23/2018; 6332089 CFM-200 10/29/2015 10/29/2018; 6360092 CFM-200 11/6/2015 11/6/2018; NS5226487 CFM-200 8/20/2014 8/20/2017; NS5514147 CFM-200 12/12/2014 12/12/2017; NS5658130 CFM-200 2/16/2015 2/16/2018; NS5712801 CFM-200 3/11/2015 3/11/2018; NS5759898 CFM-200 3/30/2015 3/30/2018; NS5864632 CFM-200 5/6/2015 5/6/2018; NS5871863 CFM-200 5/11/2015 5/11/2018; NS5945483 CFM-200 6/9/2015 6/9/2018; NS6091885 CFM-200 8/4/2015 8/4/2018; NS6126832 CFM-200 8/17/2015 8/17/2018; NS6147094 CFM-200 8/24/2015 8/24/2018; NS6360093 CFM-200 11/6/2015 11/6/2018.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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