Events

Retiro De Equipo (Recall) de Device Recall Ansell Sandel Weighted Safety Scalpel

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 Ansell Sandel Medical Industries LLC.

¿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
    67005
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0635-2014
  • Fecha de inicio del evento
    2013-11-12
  • Fecha de publicación del evento
    2014-01-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124491
  • 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
    Handle, scalpel - Product Code GDZ
  • Causa
    Select lots of sandel weighted safety scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
  • Acción
    The firm, Ansell, sent an "URGENT: VOLUNTARY RECALL OF ANSELL SANDEL WEIGHTED SAFET SCALPEL" letter dated November 11, 2013 to its customers and posted a website notification on November 11, 2013. The letter described the product, problem and actions to be taken. The customers were instructed: Do not ship SANDEL Weighted Safety Scalpel products 2210-L, 2210-N, 2211-L, 2211-N, 2215-L, 2215-N, or 2220-N to a hospital or end user with the listed lot numbers; quarantine SANDEL Weighted Safety Scalpel products in your inventory; and complete the attached response form and return it to attention: Ansell; via fax at 818-534-2510 or email sandel-cs@ansell.com. Additionally, if you have distributed this product to other accounts, please notify them of the voluntary recall and instruct them to return any outstanding stock to you as indicated in the attachment. If you have any questions or need additional information, please contact Customer Service by calling 866-764-3327 (6:00am-5:00pm PST/9:00am-8pm EST) or email sandel-cs@ansell.com

Device

Device Recall Ansell Sandel Weighted Safety Scalpel
  • Modelo / Serial
    510 K exempt Device Listing Number D129456 Model Number 2210-N LN 0563 Jan 2016 LN 2263 Jul 2016
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.
  • Descripción del producto
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade || Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA || Emergo Europe Molenstraat 15 2513 BH The Hague || The Netherlands || Made in China || Packaged in Mexico || Ansell || A manual surgical scalpel blade for making incisions in various general surgical procedures.
  • Manufacturer
    Ansell Sandel Medical Industries LLC

Manufacturer

Ansell Sandel Medical Industries LLC
  • Dirección del fabricante
    Ansell Sandel Medical Industries LLC, 19736 Dearborn St, Chatsworth CA 91311-6509
  • Source
    USFDA