Events

Retiro De Equipo (Recall) de Device Recall 3M Surgical Clipper Professional 9681

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 3M Company - Health Care Business.

¿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
    79289
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0777-2018
  • Fecha de inicio del evento
    2018-02-02
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161824
  • 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
    Razor, surgical - Product Code LWK
  • Causa
    Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. in rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy.
  • Acción
    The firm initiated their field safety action on 02/08/2018 by certified mail to customers and distributors. Larger distributor were notified by email on 02/12/2018. The notices to the distributors stated: "3M is notifying all users of the 3M" Surgical Clipper Professional 9681 of an added product warning, stressing the importance of following proper clipper charging practices as documented in the Model 9681 Clipper instructions for use. Current charging instructions recommend leaving the clipper body in the drop-in charger in between uses. Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy. 3M has received two reports of battery venting resulting in minor burn injury. 3M is adding the following product warning to emphasize the importance of proper charging practices: Warning: To avoid potential battery degradation, charge the clipper after each use and store in the drop-in charger stand when not in use. Distributors are being asked to take the following actions: " Identify those customers who have ordered the 3M" Surgical Clipper Professional 9681 or the 3M" Surgical Professional Clipper Blades 9680 beginning January 1, 2016 to date. " Communicate this Field Safety Notice to those customers." The notice to the customer stated the following: "3M is notifying all users of the 3M" Surgical Clipper Professional 9681 of an added product warning, stressing the importance of following proper clipper charging practices as documented in the Model 9681 Clipper instructions for use. Current charging instructions recommend leaving the clipper body in the drop-in charger in between uses. Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat durin

Device

Device Recall 3M Surgical Clipper Professional 9681
  • Modelo / Serial
    all
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution including US nationwide, including Puerto Rico. Singapore, Australia, Canada, Chile, Colombia, Costa Rica, Brazil, Dominica, Ecuador, Guatemala, UAE, Israel, Japan, Korea, Mexico, new Zealand, Paraguay, Peru, Taiwan, Uruguay, India, Bolivia, El Salvador, Saudi Arabia, and Thailand.
  • Descripción del producto
    3M Surgical Clipper Professional 9681
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Dirección del fabricante
    3M Company - Health Care Business, 3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144-0001
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    USFDA