Events

Retiro De Equipo (Recall) de Device Recall PD Access Vascular Access Device

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 Escalon Medical Corp.

¿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
    56610
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0132-2011
  • Fecha de inicio del evento
    2010-05-05
  • Fecha de publicación del evento
    2010-10-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94089
  • 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
    Flowmeter, blood, cardiovascular - Product Code DPW
  • Causa
    The packaging of the vascular access device may potentially become damaged, compromising the sterility of the product. use of a non-sterile product increases risk of patient infection. this recall involes: model 78050 18 gauge pd access vascular access device, model 78060 extended 18 gauge pd access vascular access device, model 75010 18 gauge smartneedle vascular access devices with expiration da.
  • Acción
    Escalon Vascular Access issued an "Urgent: Recall" letter dated May 5, 2010 to customers. The letter identified the affected product being recalled, described the problem, and the actions to be taken.. Consignees were recommended to immediately examine their inventory, quarantine the product, notify their customers, and return product affected. They also advised them that if they have further distributed the product, to please identify the customers and notify them at once of the product recall. Replacement product can be ordered from Vascular Solutions, Inc at 888-240-6001. Customer service can be contacted at 800-676-0043.

Device

Device Recall PD Access Vascular Access Device
  • Modelo / Serial
    78050 Starting with lot 1335050157 exp date 2010-04 Ending with lot 1469100138 exp date 2015-03  78060 Starting with lot 1335050222 exp date 2010-04 Ending with lot 1470100140 exp date 2015-03   75010 Starting with lot 1337050271 exp date 2010-05 Ending with lot 1469100139 exp date 2015-03
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA, including the states of AL, AR, AK, AZ, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD.MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, MN, NY, NC, ND, OH, OK OR, PA, RI, SC, SD,TN, TX UT, VA, WA, WV, and WI, and the countries of: Australia, Austria, Bahamas, Canada, Colombia, Denmark, England, Germany, Greece, Hong Kong, Italy, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, and Switzerland.
  • Descripción del producto
    PD Access Vascular Access Device. Escalon Vascular Access, Inc., 2440 South 179th Street, New Berlin, WI 53146: || Model 78050 18 Gauge GA Doppler Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in guidewire, Sterile EO, PD Access Vascular Access Device. || Model 78060 Extended 18 Gauge Doppler Guided Bare Needle Assembly, 3 1/2 in Length, 0.038 in Guidewire, Sterile EO, PD Access Vascular Access Device || Model 75010 18 Gauge 2 3/4 in Length, 0.038 in guidewire, Sterile EO, SmartNeedle Vascular Access Devices
  • Manufacturer
    Escalon Medical Corp

Manufacturer

Escalon Medical Corp
  • Dirección del fabricante
    Escalon Medical Corp, 2440 S 179th St, New Berlin WI 53146-2149
  • Empresa matriz del fabricante (2017)
    Escalon Medical Corp
  • Source
    USFDA