Asante Solutions, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0594-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

Product Classification:

Class II

Date Initiated: November 19, 2013

Date Posted: January 8, 2014

Recall Number: Z-0594-2014

Event ID: 66895

Reason for Recall:

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.

Status: Terminated

Product Quantity: 834 kits

Code Information:

Asante Catalog number: FG-4123-5 FG-4123T Unomedical Item number: 87-060-2562; Lot numbers: 0230118 0230122 5036994

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated