Retiro De Equipo (Recall) de Device Recall Customed

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 Customed, 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
    Recall
  • ID del evento
    68536
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2409-2014
  • Fecha de inicio del evento
    2014-05-20
  • Fecha de publicación del evento
    2014-08-29
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2017-08-14
  • 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
    General surgery tray (kit) - Product Code LRO
  • Causa
    Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
  • Acción
    Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Device

  • Modelo / Serial
    Product code 900-1735, 50 lots: 110102434 110112619 110112893 111010068 111020366 111030604 111040842 111051280 111061589 111071909 111082065 111082258 111092365 111102646 111102700 111112936 111112963 111123380 112010087 112010246 112020405 112030642 112041200 112051874 112062448 112072785 112083406 112114610 112125032 112125313 113015434 113025948 113026232 113036783 113057399 113057692 113057813 113068157 113078569 113089200 113099567 131110069 131110403 131110580 131210964 140111412 140211885 140312330 140412886 140513347
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
  • Descripción del producto
    MINOR LAPAROTOMY PACK - || (1) TABLE COVER 50" X 90" REINFORCED LIF || (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP || (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF || (3) TOWELS ABSORBENT 15" X 20" LIF || (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR LIF || (5) LAP SPONGE PREWASH XRD L/F || (4) DRAPE UTILITY WITH TAPE LIF || (2) LITES GLOVE LIF || (1) TUBE SUCTION CONNECT. ~" X 12' LIF || (1) COVER MAYO STAND REINFORCED LIF || (1) UTILITY BOWL 32oz || (2) UTILITY BOWL 16oz || (1) SPECIMEN CONTAINER 4oz WITH LID & LABEL || (1) CAUTERY TIP POLISHER LIF || (1) BLADE SURGICAL #10 CARBON STEEL || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) BAG SUTURE FLORAL || (1) DRAPE SHEET MEDIUM 41" X 69" LIF || (1) DRAPE LAP WITH POUCH SMS STD L/F || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA