SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Reported: June 18, 2025 Initiated: May 13, 2025 #Z-1917-2025
Product Description
SCD Comfort Knee Length Small, SKU 84021; 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? ▼
SCD Comfort Knee Length Small, SKU 84021; 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-1917-2025.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11