Cardinal Health 200, LLC: Medical Device Recall in 2024 - (Recall #: Z-3301-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888264960, Sterile; and (d) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888264986, Sterile;

Product Classification:

Class II

Date Initiated: July 24, 2024

Date Posted: October 2, 2024

Recall Number: Z-3301-2024

Event ID: 95214

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.

Status: Ongoing

Product Quantity: 24,761,100 tubes total

Code Information:

All lot numbers. UDI-DI numbers: (a) 8888264929, UDI-DI 10192253012477; (b) 8888264945, UDI-DI 10192253012491; (c) 8888264960, UDI-DI 10192253012514; and (d) 8888264986, UDI-DI 10192253012538;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated