Tube, Double Lumen For Intestinal Decompression And/or Intubation

Salem Sump PVC Tubes:

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

Salem Sump PVC Tubes:

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile;

The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

Bard PreVent Anti-Reflux Filter with ENFit, REF EN0046000

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

Bard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with ENFit, 12Fr., 48in Long, REF EN0056120

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.