Drug recall
(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929…
FDA recall event 95214 · Class II · Cardinal Health 200, LLC
Key facts
| Event ID | 95214 |
|---|---|
| Recall numbers | Z-3301-2024, Z-3302-2024 |
| Recalling firm | Cardinal Health 200, LLC |
| Product type | Devices |
| Products | (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…, (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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jul 24, 2024 |
| Report date | Oct 2, 2024 |
| City | Waukegan |
| State | IL |
| Country | United States |
| FEI number | 3001236905 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: