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
    laparoscopy kit - Product Code FDE
  • 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
    900-3178, 4 lots: 131210899 140211837 140312152 140513143
  • 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
    Laparoscopy pack, , Code 900-3178, contains: || (1) BULB SYRINGE 60cc LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) MAYO STAND COVER REINFORCED LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV || (4) TOWEL ABSORBENT 15" X 20" LIF || (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF || (3) LITE GLOVE LIF || (1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" || (1) BLADE SURGICAL# 11 || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (4) DRAPE UTILITY WITH TAPE LIF || (1) SUTURE BAG FLORAL L/F || (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR LIF || (1) CABLE LAP 10FR 4MM MALE MONOP. LIF || (1) SPECIMEN CONTAINER 4oz W/LID & LABEL || (2) SHEET% 60" X 77" DRAPE REINFORCED LIF || (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF || (1) WRAPPER 24" X 24" LIF || (1) ULTRA VERES NEEDLE 120MM LIF || (1) TROCAR ENDO.XCELL DILATING TIP 11 MM || (1) TROCAR ENDO.XCELL DILATING TIP 5MM LIF || (1) CANNULA 5MM XCEL SLEEVES LIF || (2) DENTURE CUP 8oz W/LID || (2) DRESSING NON ADH TELFA 4" X 3" || (1) CHLORAPREP 26ML APPLICATOR TEAL LIF || 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