FDA Recall: Incorrect software logic may cause frequent E1 errors

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.