Events

Retiro De Equipo (Recall) de Various DeRoyal Surgical 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
    72574
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0363-2016
  • Fecha de inicio del evento
    2015-09-10
  • Fecha de publicación del evento
    2015-12-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141577
  • 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
    These custom sterile surgical kits contain the component, ecolab ors fluid warming and slush drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
  • Acción
    DeRoyal issued their recall on 09/10/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors were asked to put the product in quarantine, place the provided labels on the products and complete. Hospitals were provided with labels to affix to the kits with the direction to discard the recalled component and notice of destruction forms to be completed and returned.

Device

Various DeRoyal Surgical Kits
  • Modelo / Serial
    Ref 89-7859.01: Lot numbers: 27369748, 27469087, 27964707, 28167081, 28207599, 28712544;  Ref 89-7859.02: Lot numbers: 35947501, 35550352, 38844461 Ref 89-7750.02: Lot numbers: 29929171, 30474952 Ref 89-7750.03: Lot numbers: 30984021, 31210924 Ref 89-8514.02: Lot numbers: 37392319, 37078506, 37109721, 36974376, 37057289, 36813530, 37086725, 37099609, 37253124, 37325378, 37401318, 37413132 Ref 89-5792.10: Lot numbers: 39821181, 39507167, 39072116, 39863866 Ref 89-7626.02: Lot numbers: 36068496, 359097163, 35543822, 35328356, 35428242, 35549693, 34939471, 33091009, 34952712 Ref 89-7626.03: Lot numbers: 39301960, 36660692, 37008882, 37210095, 37915491, 37217991, 40101164, 37519742, 38455852, 38756495, 39417057, 39714051, 39913835 Ref 89-8440.01: Lot numbers: 36674648, 36612412 Ref 89-8440.02: Lot number: 36987476
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in MO, MA, NC, CT, Kuwait.
  • Descripción del producto
    DeRoyal sterile custom surgical kits: || 1) Emergency CABG Pack Pgybk, ref 89-7859.01 || 2) Emergency CABG Pack Pgybk, ref 89-7859.02 || 3) Open Heart Pack A&B; Pgybk, ref 89-7750.02 || 4) Open Heart Pack A&B; Pgybk, ref 89-7750.03 || 5) Intl-Cardiac Surgery Pack A&B; Pgybk, ref 89-8514.02 || GEO-MED sterile custom surgical kits: || 1) Open Heart Pack Pgybk, ref 89-5792.10 || 2) Open Heart A&B; Pgybk, ref 89-7626.02 || 3) Open Heart A&B; Pgybk, ref 89-7626.03 || 4) Open Heat Pack A&B; Pgybk, ref 89-8440.01 || 5) Open Heart Pack A&B; Pgybk, ref 89-8440.02
  • 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