Events

Alerta De Seguridad para Alkaline Wash

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Abbott Laboratories Ltd.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-05-18
  • Fecha de publicación del evento
    2015-05-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150518.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: abbott laboratories alkaline wash medical device manufacturer, abbott laboratories ltd, has issued a field safety notice concerning alkaline wash, with the following details: list number: 9d31-20 lot number: 49059un14 expiration date: 4 march 2016 the manufacturer is recalling the affected product due to leaking and/or material received with loose bottle caps that may have leaked during shipment the manufacturer has given the following advice to users: - while wearing the appropriate personal protective equipment (ppe), visually inspect the inventory. if users observe any signs of leakage or loose caps, they should discontinue use and dispose of any remaining inventory of those kits in accordance with their institution’s policies and procedures. if users do not observe any signs of leakage or loose caps, they may continue to use the product following the precautions per the architect system operations manual and the safety data sheet. according to the local supplier, the affected product is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 may 2015.

Device

Alkaline Wash
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Laboratories Alkaline Wash
  • Manufacturer
    Abbott Laboratories Ltd

Manufacturer

Abbott Laboratories Ltd
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH