Events

Retiro De Equipo (Recall) de Device Recall CVS Pharmacy Plastic Sesame Street Adhesive Bandages

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 Pharmaplast S.A.E..

¿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
    58051
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1875-2011
  • Fecha de inicio del evento
    2011-02-21
  • Fecha de publicación del evento
    2011-04-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98116
  • 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
    tape and bandage, adhesive - Product Code KGX
  • Causa
    The bandages are labeled as sterile, but failed sterility testing.
  • Acción
    Pharmaplast S.A.E. called the direct account on 2/17/11 and sent a Urgent Medical device recall letter dated 2/21/11 to the direct account via overnight mail, requesting that they examine their inventory for the non-sterile adhesive bandages and quarantine them for return to Pharmaplast via sea freight. The account was instructed to contact their customers concerning the recall and return their stocks of the affected lot, which was done by telephone calls on 2/17/11. For questions regarding this Recall please call 00203-4500264

Device

Device Recall CVS Pharmacy Plastic Sesame Street Adhesive Bandages
  • Modelo / Serial
    REF CVS 826159, UPC 0 50428 95118 7, lot number 10J10
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution - Including Illinois.
  • Descripción del producto
    CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 || The device is used to cover and protect wounds.
  • Manufacturer
    Pharmaplast S.A.E.

Manufacturer

Pharmaplast S.A.E.
  • Dirección del fabricante
    Pharmaplast S.A.E., Free Zone Factory POB 37, Amria Free Zone, Kafr El Zayat, Gharbia Egypt
  • Source
    USFDA