The National Authority of Medicines and Health Products (Infarmed) has ordered the suspension of sales and the recall of a specific batch of syringes in the national market due to non-compliance in certain units.
“Non-conformities were found in some units of batch 240520 of the Cardio Natur brand syringes, reference 30MLLL, manufactured by Jiangsu Kanghua Medical Equipment Co., Ltd., including an excess of silicone oil (lubricant),” according to an official statement on the website.
Infarmed explained that the manufacturer indicated the issue resulted from a defect in the manufacturing process, which has since been resolved.
As a result of this situation, the distributor for the national market, PMH – Produtos Médicos Hospitalares, S.A., is conducting a voluntary recall of this batch.
Entities in possession of units from batch 240520 of this medical device should refrain from dispensing or using them and should contact the national distributor for their return.
