Recall of all Balanced Salt Solutions (BSS) form the manufactuer Cytosol Laboratories Inc.
2006.05.18
Product group ophthalmological technology
Reference 00418/06
Cytosol Laboratories Inc., USA recalls worldwide all Balanced Salt Solutions (BSS) (all lots, cat. No. see annex). The products are used to irrigate a patient´s eyes, ears, and/or throat during a variety of surgical procedures e.g. cataract surgeries. In the USA product lots were found to have elevated levels of endotoxin.
The recalled products were manufactured by Cytosol Laboratories Inc. for distribution under three product labels labels: „AMO Endosol“ distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana, Calif.; „Cytosol Opthalmics“ distributed by Cytosol Ophthalmics, Lenoir, NC; and „Akorn“ distributed by Akorn Inc., Buffalo Grove, III.