Cardinal Health 200, LLC recalls (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Mode…

Recall date

July 24, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3302-2024

FDA classification

Class II

Brand / firm

Cardinal Health 200, LLC

Sold / distributed

Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

(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; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888266130, Sterile; and (d) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888266148, Sterile.