The U.S. Food and Drug Administration (FDA) has announced a Class I recall—the most serious type—of specific lots of BD esophagogastric balloon tamponade tubes, used in emergency care to manage upper gastrointestinal bleeding. The recall stems from difficulties users have experienced in removing the plastic plugs from the rubber lumen, a step necessary to inflate the device’s balloons.
According to BD (Becton, Dickinson and Company), the device’s manufacturer, and its subsidiary C.R. Bard Urology and Critical Care, this issue has led to two serious injuries and one death. The company has issued updated usage instructions and notified all affected customers through official communication.
Healthcare providers using these devices are urged to follow the updated instructions closely and report any adverse events to the FDA’s MedWatch program.
Source: U.S. Food and Drug Administration, Recall Notice
https://www.fda.gov
