Events

Recall of Device Recall DANA Diabecare II insulin pumps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dana Diabecare USA LLC.

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
    29472
  • Event Risk Class
    Class 2
  • Event Number
    Z-1451-04
  • Event Initiated Date
    2004-05-26
  • Event Date Posted
    2004-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33806
  • 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
    Pump, Infusion, Insulin - Product Code LZG
  • Reason
    There is a switch malfunction that that may cause the unit not to respond when command key is depressed.
  • Action
    An email was sent to the sales representatives requesting the return of the pumps. The patients were contacted by telephone and letters requesting the return of the pumps.

Device

Device Recall DANA Diabecare II insulin pumps
  • Model / Serial
    Serial numbers: AEE001FC ¿ AEE039FC, AEE041FC, AEE043FC ¿ AEE048FC, AEE083FC ¿ AEE132FC
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, WV, PA, FL, WI, MI, TN, MD
  • Product Description
    DANA Diabecare II insulin pumps
  • Manufacturer
    Dana Diabecare USA LLC

Manufacturer

Dana Diabecare USA LLC
  • Manufacturer Address
    Dana Diabecare USA LLC, 541 Julia Street, 3rd Floor, New Orleans LA 70130
  • Source
    USFDA