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-2524-2014
  • 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=129566
  • 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
    General surgery tray (kit) - Product Code LRO
  • 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
    900-3114, 2 lots: 131210804 140111438
  • Clasificación del producto
    General and Plastic Surgery 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
    Tummy Tuck Pack- FJG, code 900-3114, contains: || (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill || (2) TOWEL ABSORBENT 15" X 20" || (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER || (1) NEEDLE HYPODERMIC 22G X 1 Y2 || (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK || (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG || (2) BOWL UTILITY QUART 32oz. || (1) COVER MAYO STAND REINFORCED || (2) MARKER SKIN WITH RULER || (1) RULER || (1) COVER TABLE REINFORCED 50" X 90" || (2) CUP DENTURE 8oz TEAL WITH LID || (6) TOWEL CLOTH HUCK BLUE || (1) TUBE SUCTION CONNECT X" X 12' || (1) YANKAUER SUCTION TUBE WITHOUT VENT || (1) SHEET% DRAPE REINFORCED 60" X 77" || (4) DRAPE UTILITY WITH TAPE || (1 0) LAP SPONGE PREWASH 18" X 18" XRD || (1) BLADE SURG. #15 CARBON STEEL || (1) BLADE SURG. #1 0 CARBON STEEL || (1) SYRINGE BULB 60cc || (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #6.5 P/F || (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F || (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7.5 P/F || (1) SKIN STAPLE 35 WIDE || (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS || (2) DRAPE SIDE 42" X 76" WITH TAPE || (1) DRAPE BOTIOM ABS REINFORCED 71" X 62" STD SMS WITH TAPE || (1 0) GAUZE SPONGE 4" X 4" 16 PLY || (1) PK. STRIP STERI CLOSURE W X 4" || 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