Reported Jan 8, 2014 · Terminated
Asante Comfort Infusion Set with 60cm tubing & 13mm 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 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination
- Kit (FG-5123-4) Manufactured forAsante Solutions Sunnyvale, CA
- Manufactured byUnomedical Lejre, Denmark
- Lot codes and dates
- Asante Catalog numberFG-4123-5
- FG-4123T Unomedical Item number87-060-2562
- Lot numbers0230118 0230122 5036994
- Amount recalled
- 834 kits
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.
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