Asante Comfort Infusion Set Recalled for Tubing Disconnection
Asante Solutions is recalling 635 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the failure of a medical device to deliver the intended dose of insulin, which poses a significant risk of harm to patients, aligning with the criteria for a Severe rating.
Plain-English summary
Asante Solutions, Inc. is recalling 635 units of the Asante Comfort Infusion Set with 110cm tubing and 13mm cannula. The product is packaged in 5-packs, singles, or inside a Combination Kit (FG-5143-4). The sets were distributed nationwide.
The recall was initiated due to reports of the infusion tubing disconnecting from the connector. This disconnection results in the leakage of insulin from the infusion set, which provides the patient with less insulin than intended. The affected items include Asante Catalog numbers FG-4143-5 and FG-4143T, and Unomedical Item number 87-110-2562. Specific lot numbers involved are 0230120, 0230124, and 5031108.
Consumers who have this product should stop using it and contact Asante Solutions for instructions on how to return the product or obtain a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
- Manufacturer
- Asante Solutions, Inc.
- Category
- Medical Device — Infusion Set
- Affected units
- 635
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 (3)
- Asante Catalog number: FG-4143-5
- FG-4143T. Unomedical Item number: 87-110-2562 Lot numbers: 0230120
- 0230124 5031108.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Asante Solutions, Inc. 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.
See all 8 products in this recall →Related recalls
Same manufacturer · Asante Solutions, Inc.
See all →- HighAsante Conset Infusion Set Recalled for Tubing Disconnects
FDA (Devices) · 2014-01-08
- SevereAsante Comfort Infusion Set Recalled for Tubing Disconnects
FDA (Devices) · 2014-01-08
- HighAsante Comfort Infusion Set Recalled for Tubing Disconnection and Insulin Leakage
FDA (Devices) · 2014-01-08
- SevereAsante Comfort Infusion Set Recalled Due to Tubing Disconnects
FDA (Devices) · 2014-01-08
- HighAsante Conset Infusion Set Recalled for Tubing Disconnection and Insulin Leakage
FDA (Devices) · 2014-01-08
Same hazard · device failure
See all →- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12