Kendall SCD Blended Comfort Sleeves Recalled for Software Logic Error
Cardinal Health is recalling Kendall SCD Blended Comfort Sleeves (Knee Length Small, SKU 84021B) due to incorrect software logic that may cause frequent E1 errors. The issue may delay 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: FDA Class II recall involving a medical device malfunction (frequent E1 errors) that may delay treatment. No reported injuries or illnesses are stated in the source; however, the potential for treatment delay in a therapeutic device warrants a High severity rating per the rubric criterion for risk-of-harm products.
Plain-English summary
Cardinal Health 200, LLC is recalling Kendall SCD Blended Comfort Sleeves Knee Length Small (SKU 84021B) for use with the Kendall SCD SmartFlow Controller. A total of 6,517 cases have been distributed.
Incorrect software logic in the device may cause frequent E1 errors (system high pressure). This issue may cause a delay in treatment or therapy.
The affected sleeves were distributed domestically to Alaska, California, Florida, Massachusetts, and Texas, and internationally to Japan. The recall applies to all lots of the product (UDI-DI/GTIN 10885380186516 for individual units and 50885380194687 for boxes).
Consumers and healthcare facilities using this product should contact Cardinal Health 200, LLC for instructions on how to proceed, including whether a replacement or corrective software update is available.
The recalled product
- Product
- Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B 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) 10885380186516 (EA) 50885380194687 (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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