Cardinal Health recalled Salem Sump stomach tubes on September 18, 2025, due to reports of valve breakage. The recall affects all lots of multiple models sold worldwide. Users must stop using these devices immediately to prevent potential harm.
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 models 266122, 266130, 266148, and more, all featuring an Anti-Reflux Valve. These tubes were distributed globally, including the U.S. and various countries. The products are nonsterile and have a known defect.
The company received complaints regarding the Anti-Reflux Valve breaking under excessive force during use. This poses a high risk of injury to patients relying on these medical devices.
Currently, there are no specific injury counts reported. However, the potential for harm exists due to the valve's failure during use.
Stop using the affected stomach tubes immediately. Follow the recall instructions provided by Cardinal Health and contact your healthcare provider for guidance.
For more information, contact Cardinal Health 200, LLC through their website or customer service number. Additional details can be found at the FDA recall page.
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