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-2375-2014
  • 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=129269
  • 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 900-1146, 36 lots: 109051127 110040868 110051198 110092116 110092352 110102423 111010024 111030547 111051146 111061483 111082046 111092345 111102659 111112945 111123320 112010025 112010277 112020314 112041069 112051672 112082330 112083209 112093735 112124923 113015489 113015687 113026040 113026202 113078237 131110156 131210626 140111140 140111777 140412582 140513068 140513475
  • 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 PACK - || (1) CAUTERY TIP POLISHER LIF || (4) DRAPE UTILITY WITH TAPE LIF || (1) INSTRUMENT POUCH || (10) LAP SPONGE PRE-WASH XRD || (1) Pk. SURGICAL STRIP W' X 6" || (2) UTILITY BOWL 32oz || (1) MAYO TRAY LARGE || (9) SHEET DRAPE 41 " X 69" MEDIUM LIF || (1) NEEDLE HYPODERMIC 18G X 1 LIF || (3) CONTAINER SPECIMEN 4oz WITH LID & LABEL || (2) Pr. SURGICAL GLOVES 7 Y2 || (2) Pr. SURGICAL GLOVES 8 || (2) EAR ULCER SYRINGE 2oz LIF || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (1) SHEET MINOR LAP 102" X 121" X 78" || (1) SAFETY SCALPEL #10 || (2) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF || (4) CLOTH HUCK TOWELS BLUE || (1) PENCIL CAUTERY ROCKER SWITCH || (2) LEGGINS W/7'' CUFF 30" X 42" || (1) DRAPE% ECONOMY 53" X 77" LIF || (1) Pk. SURGICAL STRIP 'X" X 6" || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR L/F || (2) ROUND WASH BASIN 6QT || (2) GOWN SURG. REINFORCED TOWEL/WRAP LARGE || (2) Pr. SURGICAL GLOVES 7 || (1) SKIN MARKER WITH RULER LIF || (1) Pk. STERI STRIP CLOSURE %"X 4" LIF || (1) TUBE SUCTION CONNECT. 'X" X 12' LIF || (1) SAFETY SCALPEL #15 || (1) SAFETY SCALPEL #11L/F || 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