Medical device recalls Moderate risk

Cardinal Health 200, LLC recalls SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Co…

Recall date
May 13, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1917-2025
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

SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

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