FDA-Device2014-01-08Class II
Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
Asante Solutions, Inc.
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.
Sold states
Nationwide Distribution.
Affected count
635 kits
Manufactured in
352 E Java Dr, Sunnyvale, CA, United States
Products
Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0596-2014Don't want to check this manually?
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