Cardinal Health 200 recalled its Salem Sump PVC tubes on September 18, 2025, due to reports of Anti-Reflux Valve (ARV) breakage. Excessive force during use caused the failures, posing a high hazard to patients. The recall affects all lots distributed worldwide.
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 several models of Salem Sump PVC tubes, including 10FR, 12FR, 14FR, 16FR, and 18FR sizes. The product codes range from 8888264911E to 8888268086E. These tubes were distributed worldwide.
The firm received complaints regarding breakage of the Anti-Reflux Valve (ARV) due to excessive force during use. This defect may lead to serious complications for patients reliant on these medical devices.
The recall has prompted safety concerns, though specific incident numbers are not disclosed. No injuries or deaths have been reported, but the potential for serious harm exists.
Patients and healthcare providers should stop using the affected devices immediately. Follow the recall instructions provided by Cardinal Health and contact your healthcare provider for further guidance.
For more information, contact Cardinal Health 200, LLC or visit their website. Recall notifications were sent to affected users via letter.
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