Events

Alerta De Seguridad para Disposable Surgical Gown Recall

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por PAUL HARTMANN (Asia-Pacific 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
    2012-07-23
  • Fecha de publicación del evento
    2012-07-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120723a.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: hartmann disposable surgical gown recall paul hartmann (asia-pacific ltd) has initiated a recall concerning certain lots of the hartmann foliodress gown under the following trade names:- comfort basic; comfort perfect; comfort special; protect standard; protect reinforced; protect a standard; protect a reinforced; according to paul hartmann (asia-pacific ltd), a quality inspection revealed the individual occurrence of micro-holes in a number of blisters containing sterile surgical gowns and isolation gowns. the micro-holes are unlikely to be detected through visual inspection. as a result, the sterility of affected products may be compromised. paul hartmann (asia-pacific ltd) advises users not to use the affected products any longer. product recall is on-going. according to paul hartmann (asia-pacific ltd), the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 july 2012.

Device

Disposable Surgical Gown Recall

Manufacturer

PAUL HARTMANN (Asia-Pacific Ltd)