FDA recall Z-1917-2025

Cardinal Health 200, LLC · Class II · device

Product

SCD Comfort Knee Length Small, SKU 84021; 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-1917-2025