Events

Retiro De Equipo (Recall) de Device Recall 3M Red Dot Monitoring Electrode, Catalog 2560 &38 & Novaplus Universal Monitoring Electrode V2560

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 / Medical Division.

¿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
    56488
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2383-2010
  • Fecha de inicio del evento
    2010-07-27
  • Fecha de publicación del evento
    2010-09-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93771
  • 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
    Electrode, electrocardiograph - Product Code DRX
  • Causa
    The sensing element of the 3m red dot monitoring electrode, catalog # 2560 and novaplus universal monitoring electrode #v2560 may have corrosion. in an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response.
  • Acción
    3M sent an "Urgent Medical Device Recall" letters and a "Distributor Product Recall Form" dated July 29, 2010 to customers and distributors of the 3M and Novaplus electrodes. The letters described the 3M Red Dot and Novaplus Universal products, problems and actions to be taken by customers. Customers were instructed to examine their inventory and quarantine the affected lots pending return to the firm. After completing and returning the enclosed Customer Product Recall Form to 3M, customers will be issued a Return Authorization Number and provided with instructions for return of the affected devices. Distributors were instructed to notify customers to the end user level and have them return affected lots to the distributor for forwarding to 3M, or forward the customer letter to end-users to instruct them on how to contact 3M for recovery of the device. The 3M Customer Helpline can be contacted at: 1-800-228-3957.

Device

Device Recall 3M Red Dot Monitoring Electrode, Catalog 2560 &38 & Novaplus Universal Monitoring ...
  • Modelo / Serial
    2560 LOT #'S: 2012-06 CX, 2012-06 CY, 2012-06 CZ, 2012-06 DA, 2012-06 DB, 2012-05 CN, 2012-05 CM, 2012-05 CK, 2012-05 CJ, 2012-05 CI, 2012-05 CH,2012-05 CG, 2012-05 CF, 2012-05 CE, 2012-05 CD, and 2012-05 CC. V2560 NOVATION PRIVATE LABEL LOT: 2012-05 CL.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: States of CA, FL, IL, KS, KY, MI, MO, NE, NJ, NY, OH, PA, RI, SD, TN, VA, and WI.
  • Descripción del producto
    3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring.
  • Manufacturer
    3M Company / Medical Division

Manufacturer

3M Company / Medical Division
  • Dirección del fabricante
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, Saint Paul MN 55144
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    USFDA