Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E EN
Summary
The FDA issued a Class II for Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM by Cardinal Health 200, LLC. Reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for u.
Details
Source
Device Recall
External ID
Z-0206-2026
Action Date
2025-10-29
Status
Ongoing
Category
device
Product Description
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 SUMP WITH ENFIT & ARV 16FR 48IN 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN
Lot/Code Info: 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
Quantity Affected: all lots
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-18
Company
Waukegan, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 308 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0206-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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