Cardinal Health recalls Kendall SCD Blended Comfort Sleeves (SKU 84021B) for potential software errors that may 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 Kendall SCD Blended Comfort Sleeves (SKU 84021B) that may cause treatment delays due to software errors. This affects users of the SmartFlow controller who need consistent therapy.
The software may cause frequent E1 errors (system high pressure), which can delay treatment or therapy. This means the device might not function properly when needed.
Users of Kendall SCD Blended Comfort Sleeves with SmartFlow controllers are affected. Those relying on the device for medical therapy are at higher risk.
Check for the SKU 84021B on the product label. The sleeves are sold with Kendall SCD SmartFlow controllers and have UDI-DI numbers 10885380186516 (EA) or 50885380194687 (BX).
Look for SKU 84021B on the sleeve label or packaging.
The recall is due to incorrect software logic that may cause frequent E1 errors (system high pressure), potentially delaying treatment or therapy.
Check the product label for SKU 84021B. If affected, contact Cardinal Health for guidance.
The recall states the issue may cause delays in treatment or therapy, but does not mention serious injury risks.
We’ve drafted a message you can send Kendall SCD to request your refund or repair — edit it as you like.
Subject: Recall Z-1919-2025 — Kendall SCD Kendall SCD Hello, I own a Kendall SCD that is covered by recall Z-1919-2025 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.