Cardinal Health 200 recalled Salem Sump dual-lumen stomach tubes worldwide after complaints that the anti-reflux valve breaks under normal use. The ARV breakage can compromise tube function. Hospitals and providers should stop using the devices and follow recall instructions 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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Salem Sump dual-lumen stomach tubes are enteral feeding and decompression devices used in medical settings to manage gastric contents. They come in multiple sizes and configurations and are distributed to hospitals and clinics.
The Anti-Reflux Valve is vulnerable to breakage under excessive force, potentially compromising device function and patient safety.
This recall is not described as part of a broader industry pattern.
Hospitals may need to replace affected tubes to maintain safety. The recall could affect supply chains and require provider switching to alternative enteral tubes.
Look for the recall notice and UDI codes in the FDA page and Cardinal Health recall communications.
Recalls typically finalize refund or replacement steps within weeks to months, depending on provider coordination.
Keep the recall notice, product labels, purchase records, and communications with providers for reference.
Model numbers include 264929, 264945, 264960, 264986, 5558264957, 5558264965, 5558264973, 5558264981, 8888264911, 8888268060, 8888268086. Additional identifiers include UDI references such as 10884521067196, 10884521067202, 10884521067219, 10884521067226, and 50192253008171 through 50192253008218, plus 10192253012453 and 10192253012972. All lots are affected. Worldwide distribution includes the United States and many international markets.
No injuries or incidents have been reported.
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