Cardinal Health 200, LLC

FDA Regulatory Profile

Summary

Total Recalls
275 (31 Class I)
510(k) Clearances
3
Inspections
29
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1203-2026Class IIChest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health SDecember 26, 2025
Z-0897-2026Class IIChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, UniversaNovember 12, 2025
Z-0211-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube,September 18, 2025
Z-0208-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen StomaSeptember 18, 2025
Z-0207-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12September 18, 2025
Z-0206-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR September 18, 2025
Z-0210-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen witSeptember 18, 2025
Z-0209-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE MarkeSeptember 18, 2025
Z-1918-2025Class IIKendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKMay 13, 2025
Z-1917-2025Class IISCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the KendaMay 13, 2025
Z-1919-2025Class IIKendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 8May 13, 2025
Z-1875-2025Class IICatalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumenMay 2, 2025
Z-1872-2025Class IICatalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumenMay 2, 2025
Z-1871-2025Class IICatalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumenMay 2, 2025
Z-1870-2025Class IICatalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCsMay 2, 2025
Z-1873-2025Class IICatalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumenMay 2, 2025
Z-1874-2025Class IICatalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumenMay 2, 2025
Z-1133-2025Class IICardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBONovember 8, 2024
Z-1128-2025Class IICardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBNovember 8, 2024
Z-1134-2025Class IICardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD November 8, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingMarch 24, 2016
K150151SmartGownTM surgical gownMay 21, 2015
K061308TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, June 5, 2006