Events

Recall of Device Recall Asante Comfort 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-0596-2014
  • 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=124074
  • 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 Comfort Infusion Set
  • Model / Serial
    Asante Catalog number: FG-4143-5, FG-4143T. Unomedical Item number: 87-110-2562 Lot numbers:  0230120; 0230124 5031108.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). || Manufactured for: || Asante Solutions || Sunnyvale, CA; || Manufactured by: || Unomedical || 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