FDAFDA · Food and drugs·Recall number Z-0594-2014
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
Published January 8, 2014 · Recall initiated: November 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Asante Solutions, Inc.
- Distributor
- Nationwide Distribution.
- Lot
- Asante Catalog number: FG-4123-5 FG-4123T Unomedical Item number: 87-060-2562; Lot numbers: 0230118 0230122 5036994
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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