Events

Retiro De Equipo (Recall) de Device Recall Surgical Clamp Inserts

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 Applied Medical Resources Corp.

¿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
    59416
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3005-2011
  • Fecha de inicio del evento
    2011-03-07
  • Fecha de publicación del evento
    2011-08-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102721
  • 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
    Clamp, vascular - Product Code DXC
  • Causa
    The recall was initiated because applied medical has confirmed that surgical clamp inserts, model numbers: g-8600, g-8650, g-8655, has the potential packaging nonconformance which could result in a compromise to the sterile barrier.
  • Acción
    The firm, Applied Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 11, 2011 to its customers. The letter provides customers with an explanation of the problem identified and actions to be taken. The customers were instructed to check their inventory; complete and return the attached Voluntary Recall Notification Confirmation Form via fax to Regulatory Affairs at 949-713-8832, and return the recalled Standard 86mm Inserts immediately to Applied Medical, Attn: RGA# 60308783, 22872 Avenida Empresa, Rancho Santa Margarita, CA 92688. Customers with product return questions, were instructed to contact the Sales Operations Administrator, at (949) 713-8652 or by email at cjacobson@appliedmedical.com. Customers with regulatory questions, were instructed to contact the Director, Regulatory Affairs, at (949) 713-8041 or by e-mail at sfehrenbacher@appliedmedical.com.

Device

Device Recall Surgical Clamp Inserts
  • Modelo / Serial
    1112662,1115821,1121413,1122062, 1122163,1125949,1129996,1130225, 1131354
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, and Michigan; and countries of: Japan, Israel, and Singapore.
  • Descripción del producto
    Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx || Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Dirección del fabricante
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Empresa matriz del fabricante (2017)
    Applied Medical Corporation
  • Source
    USFDA