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
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- May 13, 2025
- Posted
- June 6, 2025
- Recall Number
- Z-1918-2025
- Quantity
- 6517 cases total
- Firm Location
- Waukegan, IL
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.
Lot / Code Info
UDI-DI (GTIN) 10885380197925 (EA) 50885380197923 (BX) ALL LOTS
Root Cause
Software change control
Action Taken
On May 13, 2025, the firm began to notify customers via Urgent Medical Device Product Correction letters. Customers were informed of the issue, which exclusively impacts use of the Comfort Small Knee Sleeve. Other sleeve sizes are unaffected and operate as intended with the SmartFlow Controller. The product remains operational if the Comfort Small Knee Sleeve and SmartFlow Controller configuration is not utilized during therapy. A software update on the SmartFlow Controller is necessary before using the SmartFlow controller with the Comfort Small Knee sleeve configuration. Customers should discontinue use of the Comfort Small Knee Sleeve with the SmartFlow Controller and utilize a suitable alternative such as SM thigh or foot cuff. Customer service representatives will coordinate with customers to facilitate a software update which will allow the controllers to be utilized with the small knee sleeves without causing the error.