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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00433-1
Product Name/Description American Surgical Company (ASC ) Neuro Sponges

Products affected: Americot Blue sponges, Cotton Balls, Ray-Cot sponges,
Delicot sponges, Uniqcot sponges and Telfa sponges

Multiple item and lot numbers affected (see attached)

ARTG Numbers: 265712, 265713 and 146103
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 14/04/2016
Responsible Entity Life Healthcare Pty Ltd
Reason/Issue A failure in the sterile peel pouch has been discovered during a quality control inspection by the manufacturer, ASC. This failure may result in a small tear in the pouch of the device leading to a potential compromised sterile barrier. A leak in the sterile barrier may allow contamination of the device increasing the risk of infection. A comprehensive investigation has identified an occurrence rate of less than 0.01% for the affected lots.
Recall Action Recall
Recall Action Instructions LifeHealthcare is advising users to inspect stock and quarantine any remaining product for return. This action has been closed-out on 30/01/2017.
Contact Information 02 8114 1531 - LifeHealthcare