Device product
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
Z-0596-2014
Product summary
- Event
- Event 66895
- Status
- Terminated
- Classification
- Class II
- Quantity
- 635 kits
- Official record key
device-enforcement:Z-0596-2014
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-4143-5, FG-4143T. Unomedical Item number: 87-110-2562 Lot numbers: 0230120; 0230124 5031108.
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.