Events

Retiro De Equipo (Recall) de FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP

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 Abbott Nutrition, Abbott Laboratories.

¿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
    53207
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2252-2009
  • Fecha de inicio del evento
    2009-09-04
  • Fecha de publicación del evento
    2009-09-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84938
  • 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
    Pump, infusion, enteral - Product Code LZH
  • Causa
    The firm initiated this voluntary recall because some of its flexiflo quantum enteral pumps, have a 110-volt ac power cord plug that may crack or fail. this potential power cord plug failure may cause electrical shock and/or a delay in feeding that could represent a potential health and safety risk.
  • Acción
    An "Urgent Device Recall" letter dated September 4, 2009 was issued via FedEx overnight delivery to all direct consignees. The letter described the affected product, issue and immediate actions for customers. Direct consignees were further instructed to immediately contact affected customers and notify them about the Urgent Device Recall. Abbott Nutrition (AN) Device Call Center (DCC) will telephone those customers who do not responded promptly to the "Urgent Device Recall" letter with the completed AN Account Summary of the Flexiflo Quantum Enteral Pump Shipments. AN Device Call Center will make arrangements for the service or replacement of the recalled pumps. Please contact the AN Device Call Center at 1-877-457-0249, Monday through Friday between the hours of 8:30 am and 5:00 pm Eastern Standard Time (EST). An AN representative will work with you to arrange service or replacement of the recalled enteral pumps.

Device

FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
  • Modelo / Serial
    Model # 50596, 50598 and 59322. Pump Serial Numbers: 1000016; 1000026; 1000030; 1000031; 1000048; 1000152; 1000154; 1000350; 1000384; 1000429; 1000506; 1000523; 1000528; 1000548; 1000569; 1000609; 1000635; 1000679; 1000751; 1000870; 1000889; 1001007; 1001102; 1001107; 1001167; 1001306; 1001329; 1001372; 1001391; 1001442; 1001654; 1001693; 1001743; 1001851; 1001865; 1001893; 1001916; 1001918; 1002027; 1002028; 1002074; 1002095; 1002110; 1002117; 1002125; 1002136; 1002142; 1002143; 1002193; 1002209; 1002227; 1002292; 1002294; 1002297; 1002313; 1002315; 1002342; 1002352; 1002376; 1002420; 1002463; 1002487; 1002489; 1002641; 1002674; 1002734; 1002790; 1002823; 1002841; 1002864; 1002898; 1002951; 1002959; 1003016; 1003018; 1003059; 1003109; 1003127; 1003128; 1003176; 1003212; 1003220; 1003263; 1003317; 1003366; 1003415; 1003422; 1003465; 1003524; 1003562; 1003585; 1003617; 1003663; 1003668; 1003682; 1003701; 1003715; 1003719; 1003747; 1003759; 1003772; 1003823; 1003917; 1003935; 1003952; 1003968; 1003971; 1004140; 1004143; 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  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution (states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY).
  • Descripción del producto
    Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322. || The Flexiflo Quantum enteral pump is a medical device that is used to deliver enteral nutrition products to tube-fed patients. The pumps are generally used in hospitals, nursing homes, health care institutions and home care.
  • Manufacturer
    Abbott Nutrition, Abbott Laboratories

Manufacturer

Abbott Nutrition, Abbott Laboratories
  • Dirección del fabricante
    Abbott Nutrition, Abbott Laboratories, 625 Cleveland Ave, Columbus OH 43215-1754
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA