Cardinal Health 200 recalled Salem Sump silicone dual lumen stomach tubes on September 18, 2025. The recall affects all lots due to complaints of Anti-Reflux Valve breakage during use. Patients and healthcare providers should stop using the devices immediately.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cardinal Health 200, LLC or your healthcare provider for instructions. Notification method: Letter
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The recall includes various models of Salem Sump silicone dual lumen stomach tubes with product codes 8888265108, 8888265116, 8888265124, 8888265132, 8888265140, 8888266213, 8888266221, 8888266247, 8888266262, and 8888266288. These products were distributed worldwide, including across all U.S. states and several countries.
The company received complaints about the Anti-Reflux Valve breaking due to excessive force during use. This defect poses a high risk of injury to patients.
There are no specific numbers reported for injuries or incidents. The recall is based on multiple complaints regarding the valve breakage.
Patients and healthcare providers should stop using the affected tubes immediately. Contact Cardinal Health 200, LLC or your healthcare provider for further instructions. Follow the recall instructions provided in the notification letter.
For more information, call Cardinal Health at 1-800-200-2137 or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0208-2026.
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