Events

Recall Or Safety Alert for IV cannula

According to Central Drugs Standard Control Organization, this recall or safety alert involved a device in India that was produced by Wellmed International Industries Pvt. 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
    Recall / Safety Alert
  • Event ID
    29/Misc./3/2014-DC (64)
  • Date
    2014-07-17
  • Event Country
    India
  • Event Source
    CDSCO
  • Event Source URL
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notes / Alerts
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 India.
  • Extra notes in the data
  • Reason
    Damage of the product (iv cannula) due to fire manufactured by mis wellmed international industries, pvt. ltd, a-176 & 177, sector -63, noida, up for export to bangladesh - reg.
  • Action
    Please refer to your letter dated 23.06.2014 on the subject cited above. In this connection, the inspection of the incident site was carried out by the officials of COSCO (EZ), Kolkata and State Licensing Authority (SLA), West Bengal. The inspection team observed that material was found stored in damaged conditions and was without legible Batch No., Mfg. & Exp. Date details etc. Further, details of incidence could not be ascertained from Bongaon Municipality. The inspection team concluded that quality and quantity of the material and actual cause of incidence cannot be ascertained. In view of above, you are directed to destroy the material as per your SOP and dispose off the material as per the provisions of Biomedical Waste Management Act and other applicable laws in presence of Drugs Inspector from SLA, WB in coordination with Bongaon Municipality.

Device

IV cannula

Manufacturer

Wellmed International Industries Pvt. Ltd.