Events

Retiro De Equipo (Recall) de Device Recall Anchor Tissue Retrieval System TRS175SB

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 Anchor Products Company, 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
    57432
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1591-2011
  • Fecha de inicio del evento
    2010-12-09
  • Fecha de publicación del evento
    2011-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96203
  • 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
    laparoscope, general & plastic surgery - Product Code GCJ
  • Causa
    The metal component within the unit can break and cause a malfunction. use of the device may represent a potential health hazard if the metal component is not removed after breakage.
  • Acción
    The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.

Device

Device Recall Anchor Tissue Retrieval System TRS175SB
  • Modelo / Serial
    Code TRS175SB, lots P36N, P38N, P72N, P77N, P90N, P94N, P98N, Q05N, Q06N, Q11N, Q14N, Q24N, Q26N, Q36N and Q43N
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including state of: Missouri; and countries including: Australia, Belgium, Canada, France, Greece, Ireland, Japan, Spain and the United Kingdom.
  • Descripción del producto
    Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS175SB || The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.
  • Manufacturer
    Anchor Products Company, Inc.

Manufacturer

Anchor Products Company, Inc.
  • Dirección del fabricante
    Anchor Products Company, Inc., 52 W Official Rd, Addison IL 60101-4519
  • Empresa matriz del fabricante (2017)
    Anchor Products Company
  • Source
    USFDA