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U.S. Department of Health and Human Services

Class 2 Device Recall SCD Comfort Knee Length Small

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 Class 2 Device Recall SCD Comfort Knee Length Smallsee related information
Date Initiated by FirmMay 13, 2025
Date PostedJune 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1917-2025
Recall Event ID 96849
510(K)NumberK230028 
Product Classification Sleeve, limb, compressible - Product Code JOW
ProductSCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Code Information UDI-DI (GTIN) 10885380186516 (EA) 50885380186514 (BX) ALL LOTS
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information ContactCustomer Service
888-444-5440
Manufacturer Reason
for Recall		Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
FDA Determined
Cause 2		Software change control
ActionOn May 13, 2025, the firm began to notify customers via Urgent Medical Device Product Correction letters. Customers were informed of the issue, which exclusively impacts use of the Comfort Small Knee Sleeve. Other sleeve sizes are unaffected and operate as intended with the SmartFlow Controller. The product remains operational if the Comfort Small Knee Sleeve and SmartFlow Controller configuration is not utilized during therapy. A software update on the SmartFlow Controller is necessary before using the SmartFlow controller with the Comfort Small Knee sleeve configuration. Customers should discontinue use of the Comfort Small Knee Sleeve with the SmartFlow Controller and utilize a suitable alternative such as SM thigh or foot cuff. Customer service representatives will coordinate with customers to facilitate a software update which will allow the controllers to be utilized with the small knee sleeves without causing the error.
Quantity in Commerce6517 cases total
DistributionDomestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JOW
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