| 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 |
|
| 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 |