Kendall SCD Comfort Sleeves Pediatric Knee Length Software Error Recall
Kendall SCD Comfort Sleeves Knee Length Small Pediatric models may experience frequent E1 errors due to incorrect software logic, potentially delaying treatment or therapy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall of a medical device where the hazard—software error causing treatment delay—poses a risk of harm. The source text explicitly states no illnesses or injuries have been reported, making this a theoretical risk scenario that per the rubric warrants a score of at most 3.
Plain-English summary
Cardinal Health 200, LLC is recalling Kendall SCD Comfort Sleeves Knee Length Small, Pediatric (SKU 84021P) for use with the Kendall SCD SmartFlow controller. The product is affected by incorrect software logic that may cause frequent E1 errors indicating high system pressure.
The issue may cause delays in treatment or therapy. The recall affects approximately 6,517 cases distributed domestically within the United States to Alaska, California, Florida, Massachusetts, and Texas, as well as international distribution to Japan. All lots of the product are affected, identified by UDI-DI (GTIN) 10885380197925 (EA) and 50885380197923 (BX).
Patients and healthcare providers using these sleeves should contact Cardinal Health 200, LLC for instructions on how to address the software error or obtain replacement units. Users experiencing E1 errors should not delay seeking appropriate care and should consult their healthcare provider.
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
- Affected units
- 6,517
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
Part of a larger recall action
This product is one of 3 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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