Events

Retiro De Equipo (Recall) de Device Recall ACIST Automated Manifold Kit

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 Acist Medical Systems.

¿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
    52199
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1872-2009
  • Fecha de inicio del evento
    2009-05-11
  • Fecha de publicación del evento
    2009-08-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82491
  • 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
    Angiographic injector and syringe - Product Code DXT
  • Causa
    Acist medical systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of bt2000 kits during a procedure which can result in unsatisfactory performance of the acist bt2000 automated manifold kit.
  • Acción
    Consignees were sent on 5/11/09 a ACIST Medical Systems "Urgent: Medical Device Recall" letter dated May 11, 2009. The letter described the problem and the product. It advised consignees to discontinue the use or further distribution of the recall product and to return the inventory and the enclosed "Medical Device Recall Form". Please use the enclosed form with firms address: 7905 Fuller Rd, Eden Prairie, MD 55344. Additional questions please contact the firm at 1-877-272-2269, option 1.

Device

Device Recall ACIST Automated Manifold Kit
  • Modelo / Serial
    Lot numbers: 2968J 3088N 3168H 3178H 2968K 3088P 3168J 3308U 2968L 3088T 3168K 3468W
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, ID, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE,NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT VA, WA, and WI.The countries of CANADA and HONG KONG
  • Descripción del producto
    ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden Prairie, MN .55344. || The automated manifold kit is comprised of an injection manifold, a pressure transducer cartridge, a check valve, tubing (low, high and peristaltic pump), and a saline spike. This kit is designed for exclusive use with the ACIST CMS2000, E2000 Voyager and CVi models of Angiographic Contrast Delivery Systems. This kit is for single use.
  • Manufacturer
    Acist Medical Systems

Manufacturer

Acist Medical Systems
  • Dirección del fabricante
    Acist Medical Systems, 7905 Fuller Rd, Eden Prairie MN 55344
  • Empresa matriz del fabricante (2017)
    Bracco Spa
  • Source
    USFDA