Field Safety Notice

HPS Pharmacies wish to advise that Sartorius has issued a safety notice for Minisart^® NML / Ophthalsart syringe filters.

Affected syringe filters may release fibres and particles into the filtrate. This could lead to foreign body reactions, immunologic responses, or pulmonary or cerebral microembolism and thrombosis. Potentially affected products are shown in the following table.

The sponsor advises users to:

• Identify and quarantine all potentially affected filters. Sartorius will provide further information on affected lots;
• Contact Sartorius if an event occurred after patient treatment with an affected product; and
• Inform Sartorius of how many filters you have in stock and how many have been used by completing the Field Safety Corrective Action form.

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Sartorius on +49 551 308 3712, or your pharmacist at HPS Pharmacies.