Z-1919-2025 Class II
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2025
- Initiation Date
- May 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6517 cases total
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.
Distribution Pattern
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Code Information
UDI-DI (GTIN) 10885380186516 (EA) 50885380194687 (BX) ALL LOTS