CLASS II Device recall · Reported 8 Jan 2014 · FDA Enforcement Report

Asante Comfort Infusion Set with tubing & cannula recalled

Asante Solutions is recalling Asante Comfort Infusion Set with tubing & cannula, distributed nationwide in the US. The recall was initiated on 19 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAsante Catalog number:FG-4147-5, FG-4147T Unomedical Item number:87-110-2662; Lot numbers: 0230121 0230125 5025227.

Quantity recalled352

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0597-2014
FDA event ID: 66895
Recalling firm: Asante Solutions, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Nov 2013
FDA classified: 27 Dec 2013
Reported: 8 Jan 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

19 Nov 2013	Recall initiated by company
27 Dec 2013	Classified by FDA	+38 days
8 Jan 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is Asante Comfort Infusion Set with tubing & cannula recalled?

Yes. Asante Solutions recalled Asante Comfort Infusion Set with tubing & cannula on 19 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0597-2014.

Why was it recalled?

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.

Which lots are affected?

Asante Catalog number:FG-4147-5, FG-4147T Unomedical Item number:87-110-2662; Lot numbers: 0230121 0230125 5025227.

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
8 Jan 2014Device	CLASS II	Asante Comfort Infusion Set with tubing & cannula recalled	Asante Solutions	Packaging Defects	Nationwide
8 Jan 2014Device	CLASS II	Asante Conset Infusion Set with tubing & cannula recalled	Asante Solutions	Packaging Defects	Nationwide
8 Jan 2014Device	CLASS II	Asante Conset Infusion Set with tubing & cannula recalled	Asante Solutions	Packaging Defects	Nationwide
8 Jan 2014Device	CLASS II	Asante Conset Infusion Set with tubing & cannula recalled	Asante Solutions	Packaging Defects	Nationwide
8 Jan 2014Device	CLASS II	Asante Comfort Infusion Set with tubing & cannula recalled	Asante Solutions	Packaging Defects	Nationwide

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