Asante Conset Infusion Set Recalled for Tubing Disconnects
Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and reduced delivery.
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 the delivery of less insulin than intended, posing a risk of harm to patients, but the source text does not report specific injuries or fatalities.
Plain-English summary
Asante Solutions, Inc. is recalling Asante Conset Infusion Sets with 110cm tubing and 6mm cannula. The affected products are packaged in 5-packs, singles, or inside a Combination Kit (FG-5246-4). The infusion sets were distributed nationwide and manufactured by Convatec in Lejre, Denmark.
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 specific catalog numbers involved are FG-4246-5 and FG-4246T, and the Unomedical item number is 43-110-5266. Affected lot numbers include 0230128, 5005803, and 5030168.
Patients using these infusion sets should contact their healthcare provider or Asante Solutions for further instructions. The recall involves 454 kits. Users should verify their product's lot number and catalog number against the information provided to determine if their device is affected.
The recalled product
- Product
- Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
- Manufacturer
- Asante Solutions, Inc.
- Affected units
- 454
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-4246-5
- FG-4246T
- Unomedical Item number:43-110-5266
- Lot numbers: 0230128 5005803 5030168.
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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