Retiro De Equipo (Recall) de Device Recall Medline RF Detect Sterile XRay Detectable USP Type VII Gauze

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 Medline Industries Inc.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Gauze/sponge, internal, x-ray detectable - Product Code GDY
  • Causa
    There is the potential for the rf id tag to separate from the retaining pouch.
  • Acción
    Initially a recall letter dated 6/13/08 was sent to the direct accounts identifying 5 lots of affected lots with two reorder numbers involved, explaining that there was a lack of integrity of the retaining pouch material for the RFID gauze, and that there was a potential for the RFID tag to separate from the retaining pouch during use. It was subsequently discovered that there was only one reorder number affected by the problem and that an additional lot had been gamma sterilized. Therefore a second letter dated 6/19/08, listing the correct reorder number and the six affected lots, was sent via FedEx overnight on the same date. The accounts were requested to remove RFID gauzes with the listed lot numbers from all stock rooms, materials storage, and OR's, and return it to Medline for replacement. The accounts were requested to complete the enclosed response sheet and fax it back to Medline at 847-643-4482, indicating the amount and lot numbers of the gauzes being returned. Any questions were directed to 866-359-1704, between 8:00 AM and 5:00 PM CST. Distributors were requested to notify their accounts of the recall. If you have questions about this recall, contact Kathy Dunne at 847-970-4678 or at


  • Modelo / Serial
    reorder: NON21432RF, lots CM130002052, CM130002062, CM130002075, CM130002068, CM130002079, and CM130002110
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    California, Indiana, Missouri, Ohio, Oklahoma, Pennsylvania, Texas and Washington
  • Descripción del producto
    Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10 sponges per pack, 80 packs per case; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA, Made in China; reorder: NON21432RF
  • Manufacturer


  • Dirección del fabricante
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060
  • Empresa matriz del fabricante (2017)
  • Source