Sodium chloride

The marketing authorization holder informed its supplied customers in a letter dated February 25, 2014, that increased customer complaints have been received regarding leaks at the emoluer connection of Clear-Flex pouches. Investigations have shown a defect in the female luer lock connector. This damage can result in the need for increased force to screw the Luer Lock connector onto the Clear-Flex pouch Emoluer. As a consequence, there is an increased risk of leakage if the Luer Lock connector is not completely screwed in place:

1. Recall of the affected batches, as the alternative product "Isotonic Saline "Serumwerk" 0.9% Infusion Solution", Z.Nr. 1-23718, can be used.
2. If the alternative product cannot be used, based on the risk/benefit ratio for the patient/recipient, the product may continue to be used until a substitute is obtained and in compliance with safety precautions attached below.

Further inquiry note

am-qualitaetsmangel@basg.gv.at