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Recall Observatory FDA recall evidence

Device 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

Z-1918-2025

May 13, 2025

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 96849
Status
Completed
Classification
Class II
Quantity
6517 cases total
Official record key
device-enforcement:Z-1918-2025

Official wording

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

Code information: UDI-DI (GTIN) 10885380197925 (EA) 50885380197923 (BX) ALL LOTS

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

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software logic may cause frequent E1 errors (system high pressure). Issue