Class II

Medical Device Recall: 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

Cardinal Health 200, LLC · May 13, 2025

Reason for Recall

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

Distribution

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

States Affected

AK, CA, FL, MA, TX

Quantity Affected

6517 cases total

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1918-2025

Status: completed

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Cardinal Health 200, LLC Medical Device Recall: 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 | SafeCheck