Reported Jan 8, 2014 · Terminated
Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit…
Asante Solutions, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Asante Solutions, Inc. · 352 E Java Dr · Sunnyvale, CA · 94089-1328
Is this the product you have?
- Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4)
- Manufactured forAsante Solutions Sunnyvale, CA
- Manufactured byUnomedical, Lejre, Denmark
- Lot codes and dates
- Asante Catalog numberFG-4147-5
- FG-4147T Unomedical Item number87-110-2662
- Lot numbers0230121 0230125 5025227
- Amount recalled
- 352
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Asante Solutions, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.