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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01218-1
Product Name/Description Z Hyalin Multipacks and Z Hyalin Plus Multipacks (aqueous/vitreous (eye) humour replacement medium kit)

Z Hyalin Multipacks
Lot numbers: 1218AB, 1218AC, 1119AE, 1207AE, 1192BA

Z Hyalin Plus Multipacks
Lot numbers: 2190BA, 2192AA, 2192AB

ARTG Number: 150016
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 4/12/2012
Responsible Entity Carl Zeiss Pty Ltd
Reason/Issue The manufacturer has identified a potential issue relating to the sterile integrity of the pouches. The seal of the pouch for each individual syringe might not be adequate and sterility of the outer surface could be compromised. The sterility of the syringe contents is not affected.
Recall Action Recall
Recall Action Instructions Quarantine and dispose of the affected product appropriately.
Contact Information 02 9020 1333 - Carl Zeiss