Z-1917-2025 Class II
FDA device recall Z-1917-2025 was initiated by Cardinal Health 200, LLC on May 13, 2025 and is designated Class II. Reason for recall: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. Affected quantity: 6517 cases total.
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