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-2387-2014
  • 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=129281
  • 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
    Neurological tray - Product Code OJG
  • 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 900-1300, 20 lots: 109050993 112051747 112093868 112104141 112124943 113015633 113025937 113036226 113046883 113047325 113057419 113078249 113099270 113109990 131110171 140111097 140211640 140312065 140412551 140513082
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    1
  • ¿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
    NEURO SPINE PACK - || (1) BAG SUTURE FLORAL || (1) COVER TABLE 44" X 90" || (4) ABSORBENT TOWELS 15" X 20" UF || (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS || (4) DRAPE UTILITY WITH TAPE LIF || (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP || (1) DURAPREP SURGICAL SOLUTION 26mL UF || (1) INCISION DRAPE 23" x 17" || (1) INSTRUMENT POUCH || (2) CAUTERY TIP POLISHER LIF || (1) CAUTERY PENCIL HANDSWITCHING LIF || (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (1) YANKAUER SUCT. TUBE WITHOUT VENT LIF || (2) LITE GLOVES LIF || (1) TUBE SUCTION CONNECT. Y.." X 12' LIF || (1) SKIN MARKER WITH RULER || (1) INCISE DRAPE ANTIMICROBIAL 23"x17" LIF || (1) Pk SURGICAL STRIP W'X 6" || (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F || (20) GAUZE SPONGE 4"X 4" 16 PLY XRD LIF || (1) SCALPEL WITH HANDLE #10 STAINLESS STEEL || (5) DRAPE % ECONOMY 53" X 77" LIF || (2) TABLE COVER HD 77" X 110" L!F || (1) MAYO TRAY LARGE || (1) UTILITY BOWL 16 oz LIF || (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F || (2) SYRINGE 10cc WITHOUT NEEDLE LIL UF || (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL || (1) J VAC RESERVOIR 300 mL || 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