Company: Cardinal Health 200, LLC
Date of Enforcement Report: 6/6/2025
Class: II
PRODUCT
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Recall Number:
Z-1917-2025
REASON:
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy
RECALLING FIRM/MANUFACTURER:
Cardinal Health 200, LLC
VOLUME:
6517 cases total
DISTRIBUTION:
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.