Recall Z-1919-2025— Cardinal Health 200, LLC

Name: FDA recall Z-1919-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-13

Class II · Completed

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2025-05-13. It names one FDA 510(k) clearance: K230028. Product: Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller. Reason: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Completed
Initiated: 2025-05-13
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K230028 — Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing AssemblyCardinal Health200, LLC·cleared 2023-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.