Events

Retiro De Equipo (Recall) de DeRoyal Sterile Custom kits

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 DeRoyal Industries 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
    78517
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0199-2018
  • Fecha de inicio del evento
    2017-10-16
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159686
  • 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 - Product Code LRO
  • Causa
    Custom surgical kits contain aplicare povidone iodine prep pads which were subsequently recalled by medline industries for incorrect expiration date.
  • Acción
    DeRoyal sent an Urgent Recall Notice letter dated October 17, 2017, to the end-user level. The letter identified the affected product, problem and actions to be taken. Consignees were asked to return any product they held in stock to DeRoyal and to complete the Notice of Return Form indicating what they were returning. Credit will be issued. They were asked to complete and return the Notice of Return Form even if they no longer held any affected product. For questions call 865-362-4203.

Device

DeRoyal Sterile Custom kits
  • Modelo / Serial
    a) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide distribution in the states of GA, IN, FL, and PA
  • Descripción del producto
    DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: || a) Incision and Drainage Tray, REF 47-763.04 || b) Incision and Drainage Tray, REF 47-763.06 || c) Incision and Drainage Tray, REF 47-763.07 || d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 || e) Incision and Drainage Tray, REF 89-6818.02 || f) Plastic Pack, REF 89-7212.04 || g) Plastic Pack, REF 89-7212.05 || Product Usage: || Custom surgical and procedural kits
  • Manufacturer
    DeRoyal Industries Inc

Manufacturer

DeRoyal Industries Inc
  • Dirección del fabricante
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Empresa matriz del fabricante (2017)
    Deroyal Industries Inc.
  • Source
    USFDA