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-2336-2014
  • 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=129187
  • 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
    Angiography/angioplasty kit - Product Code OEQ
  • 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

Device

Device Recall Customed
  • Modelo / Serial
    Product code 900-610, 26 lots: 111123130 111123272 112010190 112030731 112041339 112051998 112062498 112093947 112114578 112125303 113025825 113026192 113036373 113036696 113047161 113057494 113067874 113078337 113089077 113109860 131110268 131210661 140111087 140211673 140311942 140513221
  • Clasificación del producto
    Cardiovascular 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
    ANGIOGRAPHY PACK - || ( 1) FEMORAL ANGlO. DRAPE WITH POUCH || (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF || (2) NEEDLE HYPODERMIC 21G X 1% || ( 1) TABLE COVER REINFORCED 44" X 78" LIF || (30) GAUZE SPONGES 4" X 4" 12PLY || ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS || ( 1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP || ( 1) GUIDEWIRE .035" X 150cm MOVABLE || (2) BAND BAG RUBBAND & TAPE L/F || (2) DENTURE CUP 8oz. WITH LID || ( 1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF || ( 1) NEEDLE HYPODERMIC 18G X 1 % || ( 1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F || (4) DRAPE UTILITY WITH TAPE L/F || (2) SOLUTION SURGICAL DURAREP 6ml L/F || (2) TOWEL CLAMP || (1) NEEDLE 18G X 2% AMC/4 || (4) TOWELS CLOTH HUCK BLUE || ( 1) UTILITY BOWL 16oz. LIF || ( 1) SCALPEL WITH HANDLE # 11 || 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