Device 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.
Z-0600-2014
Product summary
- Event
- Event 66895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 454 kits
- Official record key
device-enforcement:Z-0600-2014
Official wording
Reason: 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.
Code information: Asante Catalog number:FG-4246-5, FG-4246T; Unomedical Item number:43-110-5266; Lot numbers: 0230128 5005803 5030168.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.