FDA recall Z-1918-2025

Cardinal Health 200, LLC · Class II · device

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

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.

Key facts

Status: Completed
Initiation date: 2025-05-13
Report date: 2025-06-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1918-2025