Z-0594-2014Class II

Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a...

Name: Z-0594-2014 Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a...
Creator: Asante Solutions, Inc.
Published: 2013-11-19
License: https://open.fda.gov/license/

Asante Solutions, Inc. / initiated 2013-11-19 / Terminated / root cause: design

FDA source

Asante Solutions, Inc. began a recall of 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... on 2013-11-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0594-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-19
Posted: 2013-12-27
Terminated: 2014-04-24
Recalling firm: Asante Solutions, Inc.
Product: 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 code: FPA Set, Administration, Intravascular
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.
Root cause tag: design
FDA root cause: Device Design
Action: Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.
Quantity in commerce: 834 kits
Distribution: Nationwide Distribution.
Product codes and lots: Asante Catalog number: FG-4123-5 FG-4123T Unomedical Item number: 87-060-2562; Lot numbers: 0230118 0230122 5036994

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0594-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0594-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0595-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0596-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0597-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0598-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0599-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0600-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27
Z-0601-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-27

Product code FPA

K120872Class IIAsante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl Infusion PumpsUnomedical A/S Infusion Devices / cleared 2012-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)