Cardinal Health recalls pediatric Kendall SCD Comfort Sleeves (SKU 84021P) due to software errors that could delay treatment. Affected units sold with SmartFlow controllers.
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Cardinal Health recalls pediatric Kendall SCD Comfort Sleeves that may cause treatment delays due to software errors. This affects children using the SmartFlow controller with these sleeves.
The software may cause frequent E1 errors (high pressure warnings) that could delay treatment. This happens when the sleeves are used with the SmartFlow controller.
Children using Kendall SCD Comfort Sleeves with SmartFlow controllers. Parents and caregivers of pediatric patients are most at risk.
Check for SKU 84021P on the product label. The sleeves were sold with SmartFlow controllers and have UDI-DI numbers 10885380197925 (EA) or 50885380197923 (BX).
Look for SKU 84021P on the Comfort Sleeves label to confirm if affected.
The software may cause frequent E1 errors that could delay treatment when used with SmartFlow controllers.
Check for SKU 84021P on the product label. Affected units were sold with SmartFlow controllers and have UDI-DI numbers 10885380197925 (EA) or 50885380197923 (BX).
The recall record does not specify a remedy, so contact Cardinal Health for guidance.
We’ve drafted a message you can send Kendall SCD to request your refund or repair — edit it as you like.
Subject: Recall Z-1918-2025 — Kendall SCD Kendall SCD Hello, I own a Kendall SCD that is covered by recall Z-1918-2025 from Kendall SCD. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
