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
    Obstetrical kit - Product Code OKV
  • 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
    Code 900-2940, 1 lot
  • 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
    Obstetrical Surgical pack, || code 900-2940, contains: || (1) BLANKET RECEIVING 100 COTTON || (3) TOWEL ABSORBENT 15 X 20 LIF || (10) GAUZE SPONGE 4 X 4 16PLY XRD LIF || (1) SYRINGE EAR/ULCER 2oz. LIF || (1) DRAPE ABDOMINAL WITH TAPE 40X54 LIF || (2) LEGGINS W/7'' CUFF 30X42 L/F || (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF || (1) OB PAD WRAP OVERNIGHT || (1) TABLE COVER REINFORCED 50X90 LIF || (1) DRAPE UNDERBUTTOCK W/POUCH 44X35" || (1) CLAMP UMBILICAL CORD LIF || (1) BOWL PLASTIC 80oz. LIF || (1) LID FOR BOWL 80oz. CLEAR LIF || (1) BEANNIES BABY || (5) LAP SPONGE PREWASH 18X18XRD || (1) MAYO TRAY SMALL || (1) DRAPE SHEET 41X58 SMS LIF || (1) UNDERPAD 36X36 BEIGE || (1) VAGINAL PACKING XRD 4X36 8PLY 100% COTTON || (10) GAUZE SPONGE 4X4 16PLY 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