Device product
Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
Z-0601-2014
Product summary
- Event
- Event 66895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1085 kits
- Official record key
device-enforcement:Z-0601-2014
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-4249-5, FG-4249T; Unomedical Item number: 43-110-5269; Lot numbers: 0230129 5005804 5040412.
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.