Important Safety Alerts

The U.S. Food and Drug Administration (FDA) posted a medical device safety alert concerning INTRA VIA Container with PVC Ports, manufactured by Baxter Healthcare. According to the alert, particulate matter was found inside the fluid path of the affected products, including:

• Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path), 500 ml (Product code: 2B8013; Lot numbers: UR13D15112)
• Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml (Product code: 2B8011; Lot numbers: UR13D15112)

For details, please refer to the FDA website
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=69181&w=11122014⟨=eng

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 17 November 2014