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
    Accessories, operating-room, table (kit) - Product Code FWZ
  • 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 900-1062, 16 lots: 109071569 112072765 112083154 113057380 113057684 113057854 113078233 113078670 113089154 113099586 131110151 131110593 131210956 140412452 140513063 140513390
  • 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
    ARTHROSCOPY PACK- || (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF || (2) BANDAGE ELASTIC 6" X 5yrd. LIF || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT || (1) DURAPREP SURGICAL SOLUTION 26m I LIF || (1) STOCKINETIE IMPERVIOUS || (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF || (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF || (1) BAG SUTURE FLORAL LIF || (1) BLADE SURGICAL #11 CARBON STEEL || (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF || (1) SYRINGE 30cc SLIP TIP LIF || (1) TABLE COVER 44" x 90" || (1) MAYO STAND COVER REINFORCED LIF || (4) TOWELS ABSORBENT 15" X 20" LIF || (5) LAP SPONGES PRE-WASH XRD UF || (1) DRAPE SHEET 41 " x 58" SMS UF || (1) NEEDLE HYPODERMIC 22G X 1 Y:z || (1) NEEDLE HYPODERMIC 18G X 1 Y:z || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (10) GAUZE SPONGES 4" X 4" 16PL Y || 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