Cardinal Health 200, LLC: (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 D

Hazard

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

Details from the source

Reason for recall: The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. Distribution: Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile. Quantity: 24,761,100 tubes total Lot/code info: All lot numbers. UDI-DI numbers: (a) 8888266114, UDI-DI 10192253012781; (b) 8888266122, UDI-DI 10192253012804; (c) 8888266130, UDI-DI 10192253012828; and (d) 8888266148, UDI-DI 10192253012842.

UPC codes

10192253012781, 10192253012804, 10192253012828, 10192253012842

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.