Cardinal Health recalled Salem Sump dual-lumen stomach tubes worldwide after ARV breakage complaints. The anti-reflux valve can break when excessive force is used. Healthcare providers and patients should stop using the device and follow recall instructions from the manufacturer.
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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A Salem Sump stomach tube is a dual-lumen gastric decompression tube used in hospitals. The Anti-Reflux Valve is designed to prevent backflow. These devices are distributed worldwide through healthcare supply channels.
The ARV can break when excessive force is applied. Breakage may compromise valve function and could prompt immediate clinical intervention.
This recall is an expansion of RES 95214 and is not presented as part of a broader industry-wide pattern in the notice.
Hospitals may need to identify affected lots and switch to alternative devices. No injuries were reported, but ARV failure could disrupt patient care and require device replacement.
Official recall notices are hosted on FDA enforcement pages and the Cardinal Health recall site.
4-8 weeks for replacement or refund processes is commonly observed in recalls, but exact timelines are not specified.
Keep recall notices, packaging, labels, and all communications. Photograph affected devices and track return or replacement actions.
Product Codes/Product Names: 266122 Salem Sump Stomach Tube Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm); 266130 Salem Sump Stomach Tube Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm); 266148 Salem Sump Stomach Tube Dual Lumen with Anti-Reflux Valve, 18 Fr/Ch; 8888266106 Salem Sump Dual Lumen Stomach Tube, Anti-Reflux Valve 10 Fr/Ch (3.3 mm), 36"; 266130CN Salem Sump Tube 16FR with CONFIRM NOW, Nonsterile; 266148CN Salem Sump Tube 8 FR with CONFIRM NOW, Nonsterile. Distribution: Worldwide, including all US states and many countries.
ARV breakage complaints have been reported. No injuries or deaths are documented in the recall notice.
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