FDA-Device2025-06-18Class II
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Cardinal Health 200, LLC
Hazard
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Sold states
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Affected count
6517 cases total
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1919-2025Don't want to check this manually?
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