Events

Recall of Device Recall Asante Conset Infusion Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Asante Solutions, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66895
  • Event Risk Class
    Class 2
  • Event Number
    Z-0598-2014
  • Event Initiated Date
    2013-11-19
  • Event Date Posted
    2013-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124076
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, administration, intravascular - Product Code FPA
  • Reason
    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.
  • Action
    Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.

Device

Device Recall Asante Conset Infusion Set
  • Model / Serial
    Asante Catalog number: FG-4226-5, G-4147T; Unomedical Item number:43-060-5266; Lot numbers:  0230126 5005801 5030167.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) || Distributed by Asante Solutions, || Sunnyvale, CA; || Manufactured by Convatec; || Lejre, Denmark.
  • Manufacturer
    Asante Solutions, Inc.

Manufacturer

Asante Solutions, Inc.
  • Manufacturer Address
    Asante Solutions, Inc., 352 E Java Dr, Sunnyvale CA 94089-1328
  • Manufacturer Parent Company (2017)
    Asante Solutions, Inc.
  • Source
    USFDA