Skip to content
Recall Observatory FDA recall evidence

Device product

Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

Z-0595-2014

November 19, 2013

Class II

Product summary

Firm
Asante Solutions, Inc.
Event
Event 66895
Status
Terminated
Classification
Class II
Quantity
246 kits
Official record key
device-enforcement:Z-0595-2014

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-4127-5, FG-4127T Unomedical Item number: 87-060-2662 Lot numbers: 0230119 0230123 5023420 5031106

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.