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Esophagogastric Tube Recall: BD Issues Correction for Esophagogastric Balloon Tamponade Tubes due to Challenges Removing Plastic Plugs from Rubber Lumen
The FDA is aware that BD and their subsidiary, C.R. Bard Urology and Critical Care, have issued a letter to affected customers that all lots of certain esophagogastric balloon tamponade tubes have updated use instructions. Users are sometimes unable, or find it difficult, to remove the plastic plugs from the rubber lumen to inflate the gastric and/or esophageal balloons. In some cases, the devices may become damaged during the removal of the plastic plugs and may require a replacement device.
Potential health consequences include delays in diagnosis or in treatment, which may result in the onset or prolongation of hypotension and its potential short- and long-term complications, up to and including death. This issue may also result in additional and unexpected diagnostic and medical interventions to manage the patient’s bleeding. BD has reported two serious injuries and one death associated with this issue.
The FDA has classified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact the firm at productcomplaints@bd.com or call 1-844-823-5433 and say, "product complaints" when prompted.
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