Events

Recall of Device Recall One Touch Ping Insulin Pump

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

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
    54239
  • Event Risk Class
    Class 3
  • Event Number
    Z-1560-2010
  • Event Initiated Date
    2009-12-18
  • Event Date Posted
    2010-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87926
  • 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
    Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). additionally, users are unable to customize the built-in food database and pump settings using the software.
  • Action
    The recalling firm telephoned the patients/users to inform them of the problem. A letter dated 12/22/09 was also sent to users. Users will have a replacement unit sent to them so that they will be able to fully utilize the pump and the software. As a courtesy a letter dated 12/22/09 was issued to the health care provider/prescribing physician for the affected users.

Device

Device Recall One Touch Ping Insulin Pump
  • Model / Serial
    Pump serial numbers: 00-72187-15, 00-72194-15, 01-72188-15, 02-72196-15, 04-70673-15, 05-72199-15, 11-70768-15, 18-67503-15, 23-69304-15, 25-66538-15, 30-69170-15, 40-69613-15, 67-69696-15, 75-72201-15, 76-72202-15, 89-71176-15, 90-71177-15, 96-70468-15, 97-72191-15, 98-72192-15, and 99-72193-15.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The pumps were provided to patients/users in CA, CT, FL, GA, ID, MA, MO, NJ, OH, OR, PA, TX, and WA
  • Product Description
    One Touch Ping Insulin Pump using ezManager Max diabetes management software
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • Manufacturer Address
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380-3428
  • Source
    USFDA