Events

Alerta De Seguridad para Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells

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

¿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
    2014-04-23
  • Fecha de publicación del evento
    2014-04-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140423.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: baxter peritoneal dialysis transfer sets, titanium adapters, disconnect caps and clamshells medical device manufacturer, baxter healthcare, has issued a field safety notice concerning its peritoneal dialysis transfer sets, titanium adapters, disconnect caps and clamshells. the concerned product codes are 5c4160, 5c4482, 5c4129, spc4213, 5c4215p and 6ac4466h. the manufacturer provides an important safety update to the instruction for use (ifu) for the concerned products. specifically, the manufacturer is adding a contraindication statement to address iodine allergy for the manufacturer’s peritoneal dialysis products which contain iodine (i.E. povidone iodine) or for which iodine use is recommended. for patients sensitive to iodine, the use of products which contain iodine or for which iodine use is recommended could result in a contact allergy or an adverse reaction if it enters the peritoneal cavity. according to the local supplier, baxter healthcare (hong kong), the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 23 april 2014.

Device

Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare