Invima issued an alert last Thursday about the imported mask KN95 Putian Zhongjin Shoes Co Ltd, because it presents risks of “mask collapse”, “breathing difficulties” and “adverse events in patients”.
The design error was detected by the importer himself and “for this reason requested to withdraw the product from the market.”
The entity recommends in this situation that if you are using the referenced product, “discontinue use and contact the importer, distributor or dealer, 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 Providing Institutions, IPS, and health professionals, according to Invima, should refrain from using the aforementioned medical device, quarantine the referenced medical device, in the event of finding stocks and contacting 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 titular establishments, distributors and marketers, the entity establishes that they must carry out the traceability of the affected product and start the action plan established by the manufacturer.
“To the titular establishments, importers, distributors and marketers, refrain from distributing and marketing the product involveduntil I manage to implement the action plan prepared by the factory, “the bulletin reads.
Likewise, to 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 “the active search is carried out to detect adverse events or incidents involving the referenced medical device and notify Invima.”
Importers like Solindi SAS, is bringing and marketing the correct KN95 mouthpieces of the highest quality.
These meet the requirements of INVIMA and Additionally, they have national and international certificates (FDA, CE, among many others) exceeding the highest quality standards worldwide.
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