Events

Rappel Ou Alerte De Sécurité sur IV cannula

Selon Central Drugs Standard Control Organization, ce/cet/cette rappel ou alerte de sécurité concerne un dispositif en/au/aux/à India qui a été fabriqué par Wellmed International Industries Pvt. Ltd..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Safety Alert
  • ID de l'événement
    29/Misc./3/2014-DC (64)
  • Date
    2014-07-17
  • Pays de l'événement
    India
  • Source de l'événement
    CDSCO
  • URL de la source de l'événement
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.