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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