—#213779

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

FDA product code: JOW — Sleeve, Limb, Compressible
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K230028
Affected lot / code info: UDI-DI (GTIN) 10885380197925 (EA) 50885380197923 (BX) ALL LOTS

Why it was recalled

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

Root cause (FDA determination)

Software change control

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.

Timeline

Recall initiated: 2025-05-13
Posted by FDA: 2025-06-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213779. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.