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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 1
  • 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
    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


  • Modelo / Serial
    Product code 900-2516, 2 lots: 131110250 131210792
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • 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
    Laparotomy Pack, 900-2516, pack contains: || ( I) TABLE COVER44" X 90" || ( I) CAUTERY PENCIL PUSH BOTTOM || (4) TOWELS ABSORBENT 15" X 20" L/F || ( I) BULB SYRINGE 60cc LIF || (4) DRAPE UTILITY WIT APE LIF || (I) SKIN MARKER W/RULER || ( I) SUTURE BAG FLORAL LIF || ( I) Y ANKAUER SUCTION TUBE W/0 VENT LIF || (2) COUNTER NDL /BLADE IOc MAG/CLEAR || ( I) GOWN XL SMS IMPERV. REINFORCED LIF || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || ( I) GOWN SURG REINFORCED. LGE T/WRAP LIF || ( I) TUBE SUCTION CONNECT W' X 12' LIF || (2) LITE GLOVE LIF || ( 10) GAUZE SPONGE4" X 4" 16PLY XRD LIF || (2) DRAPE SHEET 41" X 58" SMS LIF || ( I) CAUTERY TIP POLISHER LIF || ( I) MERLING SKIN PREP APPLIC. 39ML LIF || ( I) UTILITY BOWL PINT 16oz LIF || ( I) SKIN STAPLE 35 WIDE LIF || ( I) UTILITY BOWL QUART 32oz LIF || ( I) BLADE SURGICAL II CARBON STEEL || ( I) TRAY MAYO SMALL || ( I) BLADE SURGICAL 20 CARBON STEEL || ( I) MAYO STAND COVER REINFORCED LIF || ( I) DRAPE LAPAROTOMY 100" X 72" X 124" W/POUCH || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
  • Manufacturer


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