Invima issued an alert last Thursday about the imported mask KN95 Putian Zhongjin Shoes Co Ltd, because it presents risks of “mask collapse”, “difficulties in breathing” and “adverse events on patients”.
The design error was detected by the importer himself and “for this reason it requested to withdraw the product from the market.”
In this situation, the entity recommends that if you are using the referenced product, “discontinue use and contact the importer, distributor or marketer, to specify the actions to follow “.
Likewise, to verify if the product has an Invima sanitary registration, consult it on the website invima.gov.co.
Meanwhile, the Health Service Providers, IPS, and health professionals, according to Invima, must refrain from using the aforementioned medical device, quarantine the referenced medical device, in the event of finding stocks and communicating with the importer, distributor or marketer.
And also ask to report “adverse events associated with the use of the medical device involved, to the Invima National Technovigilance Program”.
For the main establishments, distributors and marketers, the entity provides that they must carry out the traceability of the affected product and initiate the action plan established by the manufacturer.
“To the proprietary establishments, importers, distributors and marketers, refrain from distributing and marketing the product involved, until it manages to implement the action plan established by the factory “, reads the bulletin.
Likewise, report any adverse event associated with the use of the medical device referenced to the Invima National Technovigilance Program.
And as a measure for the National Technovigilance Network, Invima requests that from the institutional technovigilance programs “An active search is carried out for the detection of adverse events or incidents involving the referenced medical device and Invima is notified”.
Importers like Solindi SAS, is bringing and marketing the correct KN95 masks of the highest quality.
They meet the INVIMA requirements and Additionally, they have national and international certificates (FDA, CE, among many others) exceeding the highest quality standards worldwide.