Salem Sump PVC Tubes (Cardinal Health) – Valve Breakage Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Salem Sump PVC Tubes: Product Code/Product Name: 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 SUM
Brand
Cardinal Health 200, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Product Code/Product Name/UDI-DI: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 10884521779419 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 10884521779426 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 10884521779433 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 10884521779440 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 10884521779457 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 10192253012774 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 10192253012798 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 10192253012811 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 10192253012835 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 10192253012859 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 10884521779464 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN 10884521779471 All Lots
Cardinal Health 200, LLC is recalling Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR due to Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for u. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On September 18, 2025, the firm notified customers via Urgent Medical Device Product Correction Update letters. This is an update to the notice sent in July 2024 for RES 95214. The present recall includes all lots of additional product codes listed. The letter provides customers with additional guidance on how to properly use the Anti-Reflux Valve (ARV): Important Instructions: After placement of the Salem Sump tube, always inject 10ml-20ml of air before seating the Anti Reflux Valve (ARV) into the blue sump vent lumen. Instructions: 1. Seat the BLUE END of the ARV into the blue sump vent lumen of the Salem Sump tube. Insert the ARV gently into the Salem Sump tube to avoid difficult removal. 2. To cap tube, seat the WHITE END of the ARV into the suction lumen. Insert the ARV gently into the Salem Sump tube to avoid difficult removal. 3. To remove, pull valve in the same direction of assembly. Do not pull at an angle to avoid breaking the valve. Please visit https://www.mycardinalmsds.com for updated electronic IFUs.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026