Events

Retiro De Equipo (Recall) de Device Recall Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Cathet

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 Arrow International Inc.

¿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
    64593
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1057-2013
  • Fecha de inicio del evento
    2013-03-04
  • Fecha de publicación del evento
    2013-04-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116571
  • 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
    Catheter, flow directed - Product Code DYG
  • Causa
    The product specifications sheet, part of the instructions for use (ifu), for the specified product numbers, reference renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. firm is in the process of updating the labeling for these products. in the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast.
  • Acción
    Arrow sent an Urgent Medical Device Customer Notification letter dated March 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Arrow is in the process of updating the labeling; in the meantime they wanted to instruct all customers to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow settings specified in the current IFU. In addition, they are placing an insert card in kits for the specified product codes alerting them that Renografin-76 is no longer available and to select a contract medium with a viscosity of 8/4 centipose or lower for use with the pressure and flow setting specified in the current IFU. Arrow remains committed to providing high quality, safe and effective products. If you require additional information or clarification regarding this matter, please contact your Sales Representative or Arrow's Customer Service Department at (866) 396-2111.

Device

Device Recall Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiograp...
  • Modelo / Serial
    Part Numbers --AI-07035, AI-07131, AI-07135, AI-07037, AI-07132, AI-07136, AI-07130, AI-07133, AI-07137, AI-07130-J, AI-07134, AND AI-07138.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. and the countries of Australia, Dominican Republic, Uruguay, Ecuador, Chile, Taiwan, Pakistan, Colombia, Argentina, Korea Republic, New Zealand, Guatemala, Thailand, Peru, Bahamas, Philippines, Trinidad and Tobago, Japan, Ireland, India, Singapore, China, Canada and Mexico.
  • Descripción del producto
    Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. || The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic Catheter is indicated for balloon occlusion pulmonary angiography.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Dirección del fabricante
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA