Asante Conset Infusion Set Recalled for Tubing Disconnects
Asante Solutions is recalling 1,085 Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.
What this means for you
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 under-dosing of insulin, a high-risk medication, but the source text does not report any hospitalizations, serious injuries, or deaths, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Asante Solutions, Inc. is recalling 1,085 units of the Asante Conset Infusion Set with tubing and 9mm cannula. The product is distributed nationwide and is packaged in 5-packs, singles, or inside a Combination Kit (FG-5249-4). The infusion sets are manufactured by Convatec in Lejre, Denmark, and distributed by 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-4249-5 and FG-4249T, Unomedical Item number 43-110-5269, and lot numbers 0230129, 5005804, and 5040412.
Patients using these infusion sets should contact their healthcare provider or Asante Solutions for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
- Manufacturer
- Asante Solutions, Inc.
- Affected units
- 1,085
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 (4)
- Asante Catalog number:FG-4249-5
- FG-4249T
- Unomedical Item number: 43-110-5269
- Lot numbers: 0230129 5005804 5040412.
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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