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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00918-1
Product Name/Description ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Administration sets for the infusion of intravenous solutions and blood)

Product Code: 2C8819

ARTG Number: 136505
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 7/09/2012
Responsible Entity Baxter Healthcare Pty Ltd
Reason/Issue Baxter has received complaints for the BURETROL Ball-Valve products with reports of air travelling below the ball-valve in the drip chamber and into the tubing. The ball-valve component is designed to prohibit the flow of air from the burette into the tubing as the burette is emptied. Upon further investigation Baxter has determined that the ball-valve feature may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
Recall Action Recall
Recall Action Instructions Baxter is recalling all affected sets and replacing it with unaffected product codes.
Contact Information 1300 302 409 - Baxter Medical Information Services