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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Cardinal Health distributed LEADER Ultra Lubricating Eye Drops and related store-brand lubricating eye drops nationwide. The recall cites a lack of assurance of sterility. Consumers should stop using these products immediately and contact KC Pharmaceuticals for guidance.
Leader Artificial Tears Sterile Lubricant Eye Drops sold nationwide are recalled due to lack of assurance of sterility. The recall involves multiple store-brand lines distributed by Cardinal Health and others. Consumers should stop using the product immediately and follow recall guidance from KC Pharmaceuticals via email.
Medline Industries recalls 2,894 Aqua-Seal Chest Drainage Units from Cardinal Health after updating IFUs to specify adult patients 18 years and older. The devices were distributed worldwide, including California, Chile and Panama. The update clarifies intended patient population and requires action from healthcare providers to stop use until further notice.
Cardinal Health 200, LLC recalls all lots of the Salem Sump Anti-Reflux Valve worldwide after complaints of valve breakage. The recall covers CE-marked valves with multiple identifiers. Hospitals and clinicians should stop using the device immediately and follow manufacturer instructions. This notice alerts providers to check for the affected code and act now.
A high-risk recall of sulfamethoxazole and trimethoprim 800 mg/160 mg double-strength tablets is active nationwide in the United States. The Harvard Drug Group and distribution partners have halted use of a lot due to a foreign-substance finding in packaging material. No tablets tested positive for micro-organisms. Consumers should stop using the product and consult their healthcare providers.