Home / Recalls / Cardinal Health 200, LLC / Z-1917-2025

Z-1917-2025 Class II

Recalled by Cardinal Health 200, LLC — Waukegan, IL

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

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 Pattern

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

Code Information

UDI-DI (GTIN) 10885380186516 (EA) 50885380186514 (BX) ALL LOTS

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  • Z-0211-2026 Class II — Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC (September 18, 2025)
  • Z-0209-2026 Class II — Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Ref (September 18, 2025)
  • Z-1919-2025 Class II — Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall S (May 13, 2025)
  • Z-1918-2025 Class II — Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendal (May 13, 2025)