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-2479-2014
  • 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=129452
  • 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 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 900-2614, 1 lot: 140312137
  • 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
    Hip & Knee replacement pack, 900-2614, contains || (1) CAUTERY TIP POLISHER UF || (1) BAG SUTURE FLORAL || (1) TUBE SUCTION CONNECT Y." X 12' UF || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) MAYO STAND COVER REINFORCED UF || (5) TOWELS ABSORBENT 15" X 20" UF || (2) DRAPE SHEET 70" X 100" L/F || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) SKIN STAPLE 35 WIDE LIF || (1) MAYO TRAY LARGE || (1) TOP DRAPE WITH ADHESIVE 100" X 50" SMS STD L/F || (1) BULB SYRINGE 60cc || (1) UTILITY BOWL 16oz || (1) UTILITY BOWL QUART 32oz || (1) INCISION DRAPE 23" X 17" || (1) SKIN MARKER WITH RULER || (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 || (1) YANKAUER SUCTION TUBE WITHOUT VENT UF || (1) MERLING SKIN PREP APPLIC. 39ML UF || (1) BLADE SURGICAL# 10 STAINLESS STEEL || (1) SHEET SPLIT WITH ADHESIVE 108" X 77" UF || (1) *GLOVE# 7.5 SURGEON NEUTRALON LATEX || (1) * GLOVE # 8 SURGEON NEUTRALON LATEX || (1) *GLOVE# 8.5 SURGEON NEUTRALON LATEX || (3) GOWN IMPERVIOUS EXTRA REINFORCED XL LIF || (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP || (4) UTILITY DRAPE WITH TAPE UF || (1 0) GAUZE SPONGE 4" X4" 16PL Y XRD LIF || (2) BANDAGE ELASTIC WITH VELCRO 6" X 5yds || (1) BLADE SURGICAL# 20 STAINLESS STEEL || (2) LITE GLOVE UF || (1) STOCKINETIE IMPERVIOUS 12" X 48" || (1) CAUTERY PENCIL ROCKER SWITCH UF || (1) BANDAGE ESMARK 6" X 9yds UF || 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