Agency classClass IIOur severity:Severe FDA (Devices)·Z-0594-2014·Announced 2014-01-08

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.

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. 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
Hazard: tubing-disconnect
insulin-leakage
medication-under-dosage
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.

See all 8 products in this recall →

Same manufacturer · Asante Solutions, Inc.

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Asante Comfort Infusion Set Recalled for Tubing Disconnection and Insulin Leakage
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Asante Conset Infusion Set Recalled for Tubing Disconnection and Insulin Leakage
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Asante Conset Infusion Set Recalled for Tubing Disconnects
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Same hazard · tubing disconnect