Asante Conset Infusion Set Recalled for Tubing Disconnection and Insulin Leakage
Asante Solutions is recalling Conset Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and delivering less insulin than intended.
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 is classified as FDA Class II and involves a medical device defect that results in the delivery of less insulin than intended, posing a risk of harm without reported fatalities or hospitalizations.
Plain-English summary
Asante Solutions, Inc. is recalling Asante Conset Infusion Sets with 60cm tubing and 9mm cannula. The product is distributed by Asante Solutions in Sunnyvale, CA, and manufactured by Convatec in Lejre, Denmark. The recall involves 1,979 kits, which may be packaged in 5-packs, singles, or inside a Combination Kit (FG-5229-4). The products were distributed nationwide.
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. Specific lot numbers associated with the recall include 0230127, 5005802, and 5038313. The Asante Catalog numbers are FG-4229-5 and FG-4229T, and the Unomedical Item number is 43-060-5269.
Patients using these infusion sets should check their product packaging for the affected lot numbers and catalog codes. If the product matches the recalled items, users should contact Asante Solutions for further instructions on how to proceed.
The recalled product
- Product
- Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
- Manufacturer
- Asante Solutions, Inc.
- Affected units
- 1,979
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-4229-5 FG-4229T
- Unomedical Item number:43-060-5269
- Lot numbers: 0230127 5005802 5038313.
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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