Cardinal Health 200, LLC recalls Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD S…

Recall date

May 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1918-2025

FDA classification

Class II

Brand / firm

Cardinal Health 200, LLC

Sold / distributed

Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.

Why it was recalled

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller