FDA (Devices) recall action 96645
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
The agency’s own wording, quoted from the enforcement report.
C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Child) due to customer complaints that plastic plugs may be difficult or impossible to remove, preventing inflation of the gastric and esophageal balloons.
C.R. Bard Inc is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Intermediate, REF 0092300) due to reports that plastic plugs may be difficult or impossible to remove, preventing proper inflation of the gastric and/or esophageal balloons.
C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Adult) because users may find it difficult or impossible to remove the plastic plugs needed to inflate the gastric and esophageal balloons.
C.R. Bard Inc is recalling the Bard Minnesota Four Lumen Esophagogastric Tamponade Tube (REF:0092220) because users may be unable to or have difficulty removing plastic plugs needed to inflate the gastric and esophageal balloons.
C.R. Bard Inc is recalling the Bard Single Intragastric Linton Balloon Tube (REF: 0092740) because users may be unable or find it difficult to remove plastic plugs needed to inflate the gastric and esophageal balloons.