Asante Comfort Infusion Set Recalled for Tubing Disconnects
Asante Solutions is recalling 352 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 and involves a medical device defect that results in the delivery of less insulin than intended, which poses a significant risk of harm to patients.
Plain-English summary
Asante Solutions, Inc. is recalling 352 units of the Asante Comfort Infusion Set with 110cm tubing and 17mm cannula. The product is packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). The sets were manufactured by Unomedical in Lejre, Denmark, for Asante Solutions in Sunnyvale, California.
The recall was initiated due to reports of the infusion tubing disconnecting from the connector. This defect results in the leakage of insulin from the infusion set, which provides the patient with less insulin than intended. The affected units are identified by Asante Catalog numbers FG-4147-5 and FG-4147T, and Unomedical Item number 87-110-2662. Specific lot numbers include 0230121, 0230125, and 5025227.
The product was distributed nationwide. Patients using these infusion sets should contact their healthcare provider or the recalling firm for instructions on how to proceed. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark
- Manufacturer
- Asante Solutions, Inc.
- Category
- Medical Device — Infusion Sets
- Affected units
- 352
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-4147-5
- FG-4147T Unomedical Item number:87-110-2662
- Lot numbers: 0230121 0230125 5025227.
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
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