Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs Recalled by Asante Solutions, Inc. Due to Reports of the infusion tubing disconnecting from the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Asante Solutions, Inc. directly.
Affected Products
Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
Quantity: 834 kits
Why Was This Recalled?
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Asante Solutions, Inc.
Asante Solutions, Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report