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Cardinal Health 200, LLC recalls Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall
Recalled June 18, 2025 · FDA recall Z-1918-2025 · Cardinal Health 200
Hazard
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. · FDA Class II
Units
6517 cases total
Sold at
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Description
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Product
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
Manufacturer(s)
Cardinal Health 200, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →