Anmat banned two medical products | He is unknown …

The National Administration of Drugs, Food and Medical Technologies (ANMAT) banned the use, marketing and distribution throughout the national territory of two batches of medical products because “their condition and condition are unknown”, therefore “its use may become a health risk”.

By provision 3075/2021 published this Monday in the Official Journal, Anmat reported the recall of products with the following information printed on its secondary box: Válvula Cardiaca Mecánica CARBOMEDICS ORBIS, SIZE 21, REF A1-021, SN S1473889-A, to be used by 2025-02-14. Y Válvula Cardiaca Mecánica CARBOMEDICS ORBIS, SIZE 023, REF A1-023, SN S1472938-A, to be used by 2025-02-16.

These products are used to replace human heart valves whose function is affected by acquired or congenital disease, or to replace previously implanted prostheses.

The company Biosud SA informed Anmat that it had sent these medical products to the province of San Juan, but that they never reached their destination and “despite the corresponding allegations, they could not find the products or an answer that would allow them to identify their destination”.

According to the provision, “since the current state of the products is unknown and therefore their conditions and proper functioning cannot be guaranteed, the use of units of mention presents a danger to the health of patients“. For this reason, Anmat resolved the product ban.