Medical device manufacturer, Sartorius, has issued a medical device safety alert concerning its syringe filters - Minisart NML / Ophthalsart [Lot No. 00131103 & 00070103; Material Code: 16534-K]
The manufacturer has identified that the affected products may release fibres and particles (subvisible or visible) into the filtrate. This may not be suitable for medical device applications (e.g. pharmacy admixture applications in a laboratory environment before use for patient care). Usage of the affected products may result in a release of particles or fibres into the pharmacy admixture, which may enter into the human body and may lead to foreign body reactions, immunological responses, pulmonary or cerebral microembolism and thrombosis.
The manufacturer advises affected users to identify and quarantine all affected products. If an incident occurred after patient treatment, affected users should review and contact the manufacturer.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 21 January 2021