Cardinal Health 200, LLC recalled Salem Sump PVC Tubes worldwide after ARV breakage complaints. The anti-reflux valve can break under excessive force during use. Clinicians and patients should stop using the device and await 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 enteral drainage or feeding tubes used in clinical settings. The ENFit connectors standardize compatibility with feeding systems.
ARV breakage can compromise tube function and raise safety concerns during use, potentially affecting patient care.
Expansion of recall RES 95214 continues to address ARV components in enteral tubes.
Hospitals and clinics may need to halt use of affected tubes, potentially disrupting patient care and supply chains. Providers should follow recall instructions to minimize risk.
Recall pages and the FDA enforcement site provide the product codes, UDI-DI, and supplier instructions
Remediation typically progresses within weeks; follow supplier timelines and doctor orders
Keep recall letters, document tube codes, save supplier instructions, photograph packaging and labels
Product Codes/Names include: 8888264911E ENFit Salem SUMP PVC TUBE 10FR 36IN; 8888264929E ENFit Salem SUMP PVC TUBE 12FR 48IN; 8888264945E ENFit Salem SUMP PVC TUBE 14FR 48IN; 8888264960E ENFit Salem SUMP PVC TUBE 16FR 48IN; 8888264986E ENFit Salem SUMP PVC TUBE 18FR 48IN; 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN; 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN; 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN; 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN; 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN; 8888268060E ENFit Salem SUMP PVC TUBE 6FR 24IN; 888
No injuries or incidents have been reported.
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