Medical device manufacturer, Baxter Healthcare Limited is issuing a voluntary recall for all lots of BURETROL Solution Set as mentioned in the following table.
Table 1: Product code and product name of the affected devices
| Product code | Product Name |
|---|---|
| 2C7519 | INTERLINK System BURETROL Solution Set with 150mL Burette (Ball-Valve Drip Chamber) |
| 2C8819 | CLEARLINK System BURETROL Solution Set with 150mL CLEARLINK Burette (Ball-Valve Drip Chamber) |
Baxter has received complaints for the BURETROL Ball-Valve products with reports of air traveling 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. Baxter has not received reports of patient injuries or adverse events as a result of the improper function of the ball-valve.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 5 September 2012