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-2346-2014
  • 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=129240
  • 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
    Orthopedic tray - Product Code OJH
  • 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 900-741, 16 lots: 112041352 112072877 112104102 113015459 113025775 113036381 113036466 113067962 113078344 113088941 113099578 113109870 131110274 131210840 140111249 140211736
  • Clasificación del producto
    Orthopedic 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
    IMPLANTE DE ORTHOPEDIA- || 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF || (1) DURAPREP SURGICAL SOLUTION 26ml LIF || (1) BAG SUTURE FLORAL LIF || (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F || (1) CAUTERY PENCIL ROCKER SWITCH LIF || (2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX || (2) BLADE SURGICAL# 10 STAINLESS STEEL || (1) BAG GLASSINE || (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF || (2) LITE GLOVE LIF || (1) SPLIT SHEET W/ADHES 108" X 77" STD SMS UF || (1) MAYO STAND COVER REINFORCED LIF || (4) DRAPE UTILITY WITH TAPE LIF || (5) ABSORBENT TOWELS 15" X 20" LIF || (5) LAP SPONGES PRE-WASH XRD LIF || (2) DRAPE SHEET 70" X 100" STD SMS LIF || (1) MAYO TRAY LARGE || (2) * Pr. SURGEON NEUTRALON GLOVE #8% LATEX || (1) STAPLE SKIN WIDE 35 ST. LIF || (1) TOP DRAPE W/ADHES. 108" X 50" STD SMS LIF || (1) BULB SYRINGE 60cc || (2) BANDAGE ELASTIC 6" X 5"yds LIF || (2) UTILITY BOWL 32oz || (1) UTILITY BOWL 16oz LIF || (1) SKIN MARKER WITH RULER || (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" LIF || (2) ABDOMINAL PAD 8" X 7 W || (1) U-DRAPE 60" X 70" WIT APE SPLIT 6" X 21' || (2) GOWN IMPERVIOUS REINFORCED XL || (1) YANKAUER SUCTION TUBE WITHOUT VENT UF || (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE || 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