| 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 |
|
| 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 |