Kendall SCD Comfort Sleeves recalled due to software logic error
Cardinal Health is recalling Kendall SCD Comfort Sleeves (small, pediatric knee-length) due to incorrect software logic that may cause frequent system high-pressure errors, potentially delaying treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses, injuries, or hospitalizations. The software malfunction presents a risk of treatment delay in a therapeutic device, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Kendall SCD Comfort Sleeves, Knee Length Small, Pediatric (SKU 84021P) intended for use with the Kendall SCD SmartFlow Controller. The product contains incorrect software logic that may generate frequent E1 errors indicating system high pressure.
When these errors occur, the device may not function as intended, potentially delaying necessary treatment or therapy. The recall affects 6,517 cases across all lots distributed domestically to Alaska, California, Florida, Massachusetts, and Texas, as well as internationally to Japan.
Patients and healthcare providers using this product should monitor for E1 error messages. If frequent high-pressure errors are occurring, contact Cardinal Health or your healthcare facility for further guidance.
The recalled product
- 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
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- software-malfunction
- treatment-delay
- system-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI (GTIN) 10885380197925 (EA) 50885380197923 (BX) ALL LOTS
Distribution
Distributed in 5 states:
- AK
- CA
- FL
- MA
- TX
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