Events

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-2429-2014
  • Fecha de inicio del evento
    2014-05-20
  • Fecha de publicación del evento
    2014-08-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129323
  • 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 differ 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

Device Recall Customed
  • Modelo / Serial
    Product code 900-2004, 11 lots: 112030703 112061278 112114387 112114491 112114877 113068160 113078570 113089022 113099283 131110222 140613472
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • 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
    LAPAROSCOPY CHOLE PACK - || (6) TOWELS ABSORBENT 15" X 20" LIF || (1) MAYO STAND COVER REINFORCED L/F || (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF || (1) SURGICAL BLADE #11 CARBON STEEL || (1) TUR Y SET, 2LEAD L/F || (4) DRAPE UTILITY WITH TAPE LIF || (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) || (1) ULTRA VERES NEEDLE 120mm || (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF || (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" || (2) DRAPE SHEET 41" X 58" SMS || (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F || (5) LAP SPONGE PREWASH XRD LIF || (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF || (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF || (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) || (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF || (1) SURGICAL DURAPREP SOLUTION 26ML LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
    Customed, Inc

Manufacturer

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