FDA issues recall on tubes used to manage bleeding
The Food and Drug Administration has identified a Class I recall of certain lots of BD esophagogastric balloon tamponade tubes due to the potential for serious injury or death. BD said it became aware of some users encountering challenges removing the plastic plugs from the rubber lumen to inflate the balloons. BD and their subsidiary C.R. Bard Urology and Critical Care sent all affected customers a letter with updated use instructions. There have been two serious injuries and one death associated with the issue.
Related News Articles
Headline
The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with…
Headline
The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy…
Headline
The Food and Drug Administration has identified a nationwide recall. Arrow International is recommending dialysis catheter kits containing Merit Medical 16F…
Headline
The Food and Drug Administration has issued an early alert for certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines by B.…
Headline
Olympus has expanded a voluntary recall of its ViziShot 2 FLEX Needles due to complaints of device components ejecting or attaching during…
Headline
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…