Asante Comfort Infusion Set Recalled Due to Tubing Disconnects
Asante Solutions is recalling 834 Comfort Infusion Sets because 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. According to the rubric, an FDA Class II recall involving a medical device that results in significant injury or significant health risk (insulin under-dosage) is classified as Severe (Score 4).
Plain-English summary
Asante Solutions, Inc. is recalling 834 units of the Asante Comfort Infusion Set with 60cm tubing and 13mm cannula. The product is packaged in 5-packs, singles, or inside a Combination Kit (FG-5123-4). The sets were manufactured by Unomedical in Lejre, Denmark, for Asante Solutions in Sunnyvale, CA.
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 lots are 0230118, 0230122, and 5036994, with Asante Catalog numbers FG-4123-5 and FG-4123T, and Unomedical Item number 87-060-2562.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected infusion sets immediately. They should contact Asante Solutions for further instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- 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
- Manufacturer
- Asante Solutions, Inc.
- Category
- Medical Device — Infusion Sets
- Affected units
- 834
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 (2)
- Asante Catalog number: FG-4123-5 FG-4123T Unomedical Item number: 87-060-2562
- Lot numbers: 0230118 0230122 5036994
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.
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