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-2382-2014
  • 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=129276
  • 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
    Cesarean section kit - Product Code OHM
  • 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 900-1294, 18 lots: 111030560 111030815 112020527 112114630 112124933 113015688 113026042 113036408 113057858 113089182 113109717 131110166 131210694 140211638 140312063 140412594 140513078 140513477
  • Clasificación del producto
    Obstetrical and Gynecological 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
    PREMIUM CESAREAN PACK- CUSTOMED- || (1)BABY BLANKET IMP. 30" X 30" POLY ABSORBENT || (3) TOWELS ABSORBENT 15" X 20" LIF || (1) BOWL PLASTIC 80oz WITH LID || (10) LAP SPONGE PREWASH XRD LIF || (2) PAD OBSTETRICAL X-LARGE ST. || (1) MAYO STAND COVER REINFORCED LIF || (1) DRAPE SHEET 41 " X 58" SMS LIF || (1) TUBE SUCTION CONNECT. X" X 12' LIF || (1) EAR ULCER SYRINGE 2oz LIF || (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF || (1) CORD UMBILICAL CLAMP LIF || (1) DRESSING ISLAND 4" X 10" || (1) BLADE SURGICAL#10 CARBON STEEL || (1) BLADE SURGICAL#20 CARBON STEEL || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) C-SECTION DRAPE WITH POUCH || (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI III || (1) GOWN SURG. REINFORCED LARGE AAMI III TOWEL WRAP || 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