FDA-Device2014-01-08Class II
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.
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
454 kits
Manufactured in
352 E Java Dr, Sunnyvale, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0600-2014Don't want to check this manually?
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