Class II U.S. Food and Drug Administration

Cardinal Health 200, LLC Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E recall: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage

Recall published 12 months ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0206-2026
Published
October 29, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Cardinal Health 200, LLC
Product type
Medical devices
Units affected
all lots
Distribution
Nationwide
Made in
United States
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
UPC codes
10884521779419, 10884521779426, 10884521779433, 10884521779440, 10884521779457, 10192253012774, 10192253012798, 10192253012811, 10192253012835, 10192253012859, 10884521779464, 10884521779471

Products covered by this recall

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

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10884521779419
  • 10884521779426
  • 10884521779433
  • 10884521779440
  • 10884521779457
  • 10192253012774
  • 10192253012798
  • 10192253012811
  • 10192253012835
  • 10192253012859
  • 10884521779464
  • 10884521779471

Model or item number

On the rating label, the box or the instruction sheet.

  • UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Cardinal Health 200, LLC — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Cardinal Health 200, LLC — 3651 Birchwood Dr, Waukegan, IL, 60085-8337

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Cardinal Health 200, LLC medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10884521779419, 10884521779426, 10884521779433; model number UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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