Cardinal Health 200 LLC expanded a worldwide recall of Salem Sump silicone dual-lumen stomach tubes after complaints of anti-reflux valve breakage. The valve can fracture under normal use, potentially compromising tube function. Healthcare providers and patients must stop using the device immediately and follow the manufacturer’s recall instructions.
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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Salem Sump tubes are medical devices used for gastric decompression in clinical settings. They come in multiple sizes and configurations for radiopaque visualization and ARV variants.
Excessive force can cause Anti-Reflux Valve breakage, potentially compromising tube function and patient safety.
This recall is not described as part of a broader industry pattern in the provided notice.
Immediate halt of device use is required in clinical settings to prevent potential device malfunction or patient harm.
Inspect packaging and device labeling for product codes and ARV configurations. Official identifiers may appear on the tube or box.
4-8 weeks for refund or replacement processing once initiated.
Keep all receipts, correspondences, and photos of affected devices and labels for records.
Product codes/names include 8888265108 to 8888265140 for Salem Sump silicone dual-lumen tubes with radiopaque lines, and 8888266213 to 8888266288 for Salem Sump TM variants with anti-reflux valves. Sizes range from 10 Fr to 18 Fr with lengths up to 48 in (122 cm). Products listed also include radiopaque-line versions and anti-reflux valve versions. Distribution is worldwide, including U.S. nationwide and numerous international markets.
No injuries or incidents have been reported.
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