# FDA recall Z-3301-2024

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2024-07-24.

## Product

(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;

## 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.

## Key facts

- **Recall number:** Z-3301-2024
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-24
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3301-2024

## Citation

> AI Analytics. FDA recall Z-3301-2024. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-3301-2024. Source: US FDA. Licensed CC0.

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