Agency classClass IIOur severity:High FDA (Devices)·Z-0595-2014·Announced 2014-01-08

Asante Comfort Infusion Set Recalled for Tubing Disconnection and Insulin Leakage

Asante Solutions is recalling 246 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery to patients.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that results in the delivery of less insulin than intended, posing a risk of harm to patients, but the source text does not report specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Asante Solutions, Inc. is recalling 246 units of the Asante Comfort Infusion Set with 60cm tubing and 17mm cannula. The product is packaged in 5-packs, singles, or inside a Combination Kit (FG-5127-4). 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 disconnection results in the leakage of insulin from the infusion set, which provides the patient with less insulin than intended. The affected lots are 0230119, 0230123, 5023420, and 5031106, associated with Asante Catalog numbers FG-4127-5 and FG-4127T, and Unomedical Item number 87-060-2662.

The product was distributed nationwide. Patients using these infusion sets should stop using the affected units and contact their healthcare provider or Asante Solutions for replacement or further instructions.

The recalled product

Product: Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
Manufacturer: Asante Solutions, Inc.
Category: Medical Device — Infusion Set
Hazard: tubing-disconnection
insulin-leakage
under-dosing
Affected units: 246

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 (1)

Asante Catalog number: FG-4127-5

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.

See all →

High
Asante Conset Infusion Set Recalled for Tubing Disconnects
FDA (Devices) · 2014-01-08
Severe
Asante Comfort Infusion Set Recalled for Tubing Disconnects
FDA (Devices) · 2014-01-08
Severe
Asante Comfort Infusion Set Recalled Due to Tubing Disconnects
FDA (Devices) · 2014-01-08
High
Asante Conset Infusion Set Recalled for Tubing Disconnection and Insulin Leakage
FDA (Devices) · 2014-01-08
High
Asante Conset Infusion Set Recalled for Tubing Disconnects
FDA (Devices) · 2014-01-08

Same hazard · tubing disconnection