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.
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 PVC Tubes with Anti-Reflux Valve are used in clinical settings to manage enteral or related fluid pathways.
The ARV can break when subjected to excessive force, potentially compromising device function and patient safety.
This recall is not described as part of a broader industry pattern.
Clinicians and facilities may need to replace affected ARV components, leading to workflow disruptions and potential treatment delays.
Refer to FDA enforcement page and Cardinal Health recall notices for instructions.
Remediation steps will be provided by Cardinal Health; typical processing timelines vary by facility, but expect several weeks.
Document all identified devices, associated lot numbers, and communications with Cardinal Health 200.
Product Code/Product Name: 266197 Salem Sump Anti-Reflux Valve (CE Marked) UDI-DI: 10884527022762 Other identifiers: 8888266197, 10192253012866 Quantity: All lots Distribution: Worldwide, including US states listed and numerous countries Sold through: Healthcare channels (not consumer retailers)
No injuries or incidents have been reported.
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