Events

Retiro De Equipo (Recall) de Device Recall Cholangioscopy Access Balloon

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 Cook Endoscopy.

¿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
    57573
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0925-2011
  • Fecha de inicio del evento
    2010-12-23
  • Fecha de publicación del evento
    2011-01-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96675
  • 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
    Catherer, biliary, diagnostic - Product Code FGE
  • Causa
    Product defect; there is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death.
  • Acción
    The firm, Cook Medical, sent an "URGENT: PRODUCT RECALL" letter dated January 7, 2011, to all customers. The letter described the product, problem and the actions to be taken by the customers. The customers were instructed to quarantine any affected product and return to Cook Medical. If they are distributors, they were instructed to contact their customers, direct them to quarantine any affected product and coordinate the return of the affected product to Cook Medical. The customers were also instructed to complete and return the bottom of the letter and send to Cook Medical as well as the PRODUCT RECALL EFFECTIVENESS SURVEY via fax at 812-339-7316 or scanned and emailed to CustomerRelationsNA@cookmedical.com. Note: All non-responding customers will receive a total of three (3) recall notifications ( two (2) follow up requests for a response in addition to the initial recall notification). Should you have any questions, please contact the Customer Relations Department at Cook Medical for more information. Please use CustomerRelationsNA@cookmedical.com or call toll free at 1-800-457-4500, press 4 then enter extension 2146.

Device

Device Recall Cholangioscopy Access Balloon
  • Modelo / Serial
    Reorder number: DPOC-15, Lot numbers: W2834630, W2835211, W2871208, W2871209, W2889215, W2889216, W2889217, W2889218, W2899398, W2899399, W2902200, W2902201, W2907649, W2907650, W2910395, W2910396, W2914136, W2914137, W2916501, W2916502, W2918945, W2918946, W2920993, W2920994, W2926799, W2926800, W2928562, W2928563, W2930338, W2930882, W2932781, W2932858, W2935202, W2935243 and WR2926438.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..
  • Descripción del producto
    DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 || This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
  • Manufacturer
    Cook Endoscopy

Manufacturer

Cook Endoscopy
  • Dirección del fabricante
    Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA