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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01329-1
Product Name/Description	CompoStop Flex 3F T&B - 100/600/1300 - PLT Pooling - processing and leuko reduction system (Blood donor set) Article Code: T5000 Batch 40GH28GA00 ARTG Number: 149450
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	17/12/2013
Responsible Entity	Fresenius Kabi Australia Pty Limited
Reason/Issue	Fresenius Kabi has decided to take this precautionary action due to possible leakage at the welding, near the position of the twist off connector. As such, the sterility may be compromised.
Recall Action	Recall
Recall Action Instructions	Fresenius Kabi is requesting their customers to discontinue use of batch 40GH28GA00 including any blood components stored in the products. Units from the affected batch are required to be returned to Fresenius Kabi.
Contact Information	1300 361 004 - Fresenius Kabi Australia Medical Affairs