Events

Safety Alert for Urine collecting bag for 2000 ML, Brand: Sigma

According to Digemid, this safety alert involved a device in Peru that was produced by CHANGSHU TAINING MEDICAL DEVICES CO, LTD.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-06-24
  • Event Country
    Peru
  • Event Source
    Digemid
  • Event Source URL
    http://www.diresalima.gob.pe/diresa/descargar/DIRECCION%20EJECUTIVA%20DE%20MEDICAMENTOS%20Y%20DROGAS/EVALUACION-PRODUCTOS/2016/Memorando_451_2016.pdf
  • Notes / Alerts
    Peruvian data is current through August 2018. All of the data comes from Digemid, 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 recall data from the U.S. and Peru.
  • Extra notes in the data
  • Reason
    Suspension of the marketing and / or of the national distribution by immobilizing said batch of the product.

Device

Urine collecting bag for 2000 ML, Brand: Sigma

Manufacturer

CHANGSHU TAINING MEDICAL DEVICES CO, LTD
  • Manufacturers representative
    Utilitarios Medicos S.A.C.
  • Source
    Digemid