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Asante Solutions, Inc. recalls Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit
Recalled January 8, 2014 · FDA recall Z-0597-2014 · 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
352
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 Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark
Manufacturer(s)
Asante Solutions, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →