Skip to content
Recall Observatory FDA recall evidence

Device product

Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.

Z-0599-2014

November 19, 2013

Class II

Product summary

Firm
Asante Solutions, Inc.
Event
Event 66895
Status
Terminated
Classification
Class II
Quantity
1979 kits
Official record key
device-enforcement:Z-0599-2014

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-4229-5 FG-4229T; Unomedical Item number:43-060-5269; Lot numbers: 0230127 5005802 5038313.

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.