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
Reported: June 18, 2025 Initiated: May 13, 2025 #Z-1918-2025
Product Description
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
Reason for Recall
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Details
- Recalling Firm
- Cardinal Health 200, LLC
- Units Affected
- 6517 cases total
- Distribution
- Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cardinal Health 200, LLC. Units affected: 6517 cases total.
Why was this product recalled? ▼
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2025. Severity: Moderate. Recall number: Z-1918-2025.
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