# FDA recall Z-0206-2026

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2025-09-18.

## 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 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

## 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.

## Key facts

- **Recall number:** Z-0206-2026
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-18
- **Report date:** 2025-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0206-2026

## Citation

> AI Analytics. FDA recall Z-0206-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0206-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*