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Asante Solutions, Inc. recalls Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-
Recalled January 8, 2014 · FDA recall Z-0600-2014 · Asante Solutions
Hazard
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. · FDA Class II
Units
454 kits
Sold at
Nationwide Distribution.
Description
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
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(s)
Asante Solutions, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →