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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00166-1
Product Name/Description	Z Hyalin Multipack and Z Hyalin Plus Multipack Z Hyalin Multipack Lot numbers: 1192BB, 1192BD ARTG number: 150016 Z Hyalin Plus Multipack Lot numbers: 2218AA, 2218AB. 2228AA, 2194AA, 2192AP ARTG number: 150017
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	22/02/2013
Responsible Entity	Carl Zeiss Pty Ltd
Reason/Issue	The manufacturer has determined a potential issue relating to the sterile integrity of the pouches contained in the Z Hyalin Multipack and Z Hyalin Plus Multipack. The content of the syringe has not been compromised, however the seal of the pouch for each individual syringe may not be adequate and sterility of the outer surface of the syringe could be compromised. This recall action was undertaken prior to notification to the TGA.
Recall Action	Recall
Recall Action Instructions	Affected batches should be identified and immediately returned to Carl Zeiss Pty Ltd. All lot numbers should be examined for package inegrity prior to use, as stated in the instructions for use.
Contact Information	02 9020 1333 - Carl Zeiss Surgical Ophthalmology