Class II — Cardinal Health 200, LLC
| Recalling firm | Cardinal Health 200, LLC |
|---|---|
| Registered facility | View this company's 35 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 18 Fr/Ch 8888266106 Salem Sump" Dual Lumen Stomach Tube, Anti-Reflux Valve 10Fr/Ch (3.3 mm), 36" 266130CN Salem Sump" Tube 16FR with CONFIRM NOW, Nonsterile 266148CN Salem Sump" Tube 8 FR with CONFIRM NOW, Nonsterile |
| Quantity | all lots |
| 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, Denm… |
| Initiated | 2025-09-18 |
| Classified | 2025-10-17 |
| Recall number | Z-0210-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cardinal Health 200, LLC (Z-0210-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97539/
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