Recall Z-1917-2025 ยท JOW Sleeve, Limb, Compressible
Cardinal Health 200, LLC
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
| Date | Jun 6, 2025 (initiated May 13, 2025) |
| Status | Completed |
| Reason | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. |
| Root cause | Software change control |
| Action | 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 |
| Quantity | 6517 cases total |
| Distribution | Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cardinal Health200, LLC, Apr 3, 2023 |