Events

Retiro De Equipo (Recall) de Device Recall 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
    78843
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0334-2018
  • Fecha de inicio del evento
    2017-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160713
  • 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
    Deroyal manufactured custom sterile surgical kits containing the covidien-dover(tm) irrigation tray with piston syringe that contains the medline aplicare povidone iodine prep pads. the prep pads were subsequently recalled because medline aplicare determined the product would not support the 36 month expiration date listed on the label.
  • Acción
    The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 12/19/2017 to its Consignees overnight. The letter describe the product, problem and actions to be taken. The Consignees were instructed to identify affected product; place in quarantine to prevent further use, and complete and return the Affected Products Listing form to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than 1/15/2018, even if you no longer have any inventory. If you have questions or need assistance with the recall, please email jmarsh@deroyal.com or call by phone 865-362-4203 or email us at recalls@deroyal.com.

Device

Device Recall DeRoyal Sterile Custom kits
  • Modelo / Serial
    (a) Lot number: 38527131 (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to states of: CA and MO.
  • Descripción del producto
    DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: || (a) Shoulder Arthroscopy Pack 89-8686.01 || (b) Shoulder Arthroscopy Pack 89-8686.02 || (c) Knee Arthro Pack 89-8687.01 || (d) Knee Arthro Pack 89-8687.02 || Product Usage: general surgical
  • 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