Defect Correction for Minisart® Filters

HPS Pharmacies wish to give notice that Sartorius Australia, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect correction for Minisart^® syringe filters as follows:

Minisart^® Syringe Filters
ARTG 315772

Product codes: Minisart^® 16534-K, 17597-K, 16555-K, 16596-HYK, 17575-ACK, 17594-K.

This product defect correction has been initiated due to two changes in the protocols for the use of these filters. The instructions for use will be updated to include this new information. In the meantime, the manufacturer requests that staff familiarise themselves with the following information:

• The specification limitation regarding the maximum pressure not to exceed (1 bar) while using the filters 16596-HYK and 17575-ACK in the OUT-IN direction; and
• The warning regarding EO (ethylene oxide) sterilised filters which should not be used for premature neonates, stem cells and embryos related applications (devices 16534-K, 17597-K, 16555-K, 16596-HYK, 17575-ACK, 17594-K).

Sartorius Australia advises that no adverse events have been associated with this issue. This is an information-related update only. Minisart^® syringe filters may continue to be used; there is no need to quarantine stock. Suppliers have just notified HPS Pharmacies of this issue; click here to download the customer acknowledgement form from Sartorius.

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 Australia on (03) 8762 1807, or your pharmacist at HPS Pharmacies.

Download PDF