Retiro De Equipo (Recall) de Device Recall Comfort EarLoop Face Mask

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 Maytex Corp.

¿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
    65160
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1451-2013
  • Fecha de inicio del evento
    2013-05-15
  • Fecha de publicación del evento
    2013-06-04
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2013-10-29
  • Fuente del evento
    USFDA
  • 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
    Mask, surgical - Product Code FXX
  • Causa
    Recent lab testing conducted in march 2013 indicates that the product does not meet the standard of "differential pressure of only 1.6 delta p (mm h2o/cm2)" as indicated on the box/package of the product; and also product manufactured between 2008 - 2012 cannot be guaranteed as fluid resistant.
  • Acción
    The firm, Maytex Corporation, sent a "MEDICAL DEVICE SAFETY NOTICE" dated May 15, 2013, to all its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately contact your medical professional for treatment and contact Maytex Corporation to file a complaint should any illness or injury occur; discontinue use of the product if you detect any potential health hazards; if this product has been further sold or distributed, notify your customers to the retail level and send copies of safety notice to customer/users; and complete and promptly return the enclosed Medical Device Safety Notice Return Response Acknowledgement and Receipt form via mail to: Maytex Corporation 23521 Foley Street, Hayward CA 94545; fax at; 510-786-0209; email: www.maytex18@aol.com or by delivery to Maytex Corporation. Maytex Corporation has temporarily taken down their Website at www.maytexcorp.com to correct the wrong product specifications as described in the notice. If you have any questions, contact Maytex Corporation at 1-800-462-9839 or email: maytex18@aol.com Monday through Friday, 8:30 AM to 5:00 PM Pacific Time.

Device

  • Modelo / Serial
    All cases of item #: 3100 face mask with PO #.  PO #, Date of receipt:  809-01, 2/5/08; 837-02, 7/29/08; 852-03, 10/10/08; 901-01, 2/3/09; 921-02, 6/8/09; 923-03, 7/8/09; 926-04, 8/26/09; 931-05, 11/10/09; 942-06, 12/16/09; 001-01, 2/17/10; 003-03, 4/12/10; 002-02 , 3/24/10; 003-03A, 7/23/10; 042-04, 11/29/10; 105-01, 1/31/11; 117-02, 4/29/11; 127/03, 7/8/11; 147-04, 12/16/11; 202-01, 3/8/2012; 224-02, 5/24/2012; 235-03, 9/12/2012; 253-04 , 12//192012
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, MA, MD, ME, MI, MN, MO, MT, NE, NH, NJ, NM, NY, OK, OR, PA, PR, TN, TX, UT, WA, and WI; and country of: Mexico.
  • Descripción del producto
    Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA || Ear-loop face mask for basic medical/dental procedures.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Maytex Corp, 23521 Foley St, Hayward CA 94545-1676
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA