Events

Recall of Animas IR1200 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
    49476
  • Event Risk Class
    Class 1
  • Event Number
    Z-0293-2009
  • Event Initiated Date
    2008-08-04
  • Event Date Posted
    2008-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73594
  • 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
    Insulin infusion pump - Product Code LZG
  • Reason
    Unintentional rebooting: pump products exhibit an intermittent loss of power due intermittent loss of contact between battery cap and battery canister resulting in the device resetting. the failure of the battery cap may result in failure of the device to administer insulin therapy which may result in hyperglycemia.
  • Action
    The recalling firm issued a notification letter to the patients with insulin pumps on 8/5/08 to inform them of the problem and that they needed to replace the battery. The recalling firm contacted OneTouch Ping users by telephone on 8/5/08 for this issue and another issue. The recalling firm issued letters to distributors informing them of the problem and notified customers to replace the batteries. In addition, a letter was issued to physicians to alert them of the situation with regard to current patients. Consumers can contact 1-800-423-4087 for additional information or questions.

Device

Animas IR1200 Insulin Pump
  • Model / Serial
    Part Numbers: 100-172-04, 100-200-00, 100-200-02, 100-200-03, 100-200-05, 100-200-08, 100-200-51, 100-200-53, 100-200-60, 100-200-61, 100-200-64, 100-200-65, 100-200-66, 100-201-00, 100-201-02, 100-201-03, 100-201-08, 100-201-51, 100-201-53, 100-201-63, 100-201-64, 100-201-65, 100-202-00, 100-202-02, 100-202-03, 100-202-04, 100-202-08, 100-202-51, 100-202-53, 100-202-60, 100-202-61, 100-202-64, 100-202-65, 100-202-66, and 100-400-00. Serial Numbers: 00-58941-10, 00-65798-10, 00-65879-10, 00-65886-10, 00-65893-10, 00-65967-10, 00-65974-10, 00-65981-10, 01-59576-10, 01-65799-10, 01-65887-10, 01-65894-10, 01-65968-10, 01-65975-10, 01-65982-10, 02-65888-10, 02-65895-10, 02-65969-10, 02-65990-10, 03-65889-10, 03-65896-10, 03-65991-10, 04-64999-10, 04-65992-10, 05-65993-10, 06-65899-10, 06-65897-10, 06-65994-10, 07-65988-10, 07-65995-10, 08-65989-10, 08-65996-10, 10-58958-10, 15-58977-10, 34-64025-10, 37-65102-10, 37-66000-10, 38-64029-10, 38-66001-10, 39-61283-10, 39-65104-10, 39-66002-10, 40-63154-10, 40-65024-10, 40-65112-10, 40-66003-10, 40-66010-10, 41-52199-10, 41-65025-10, 41-65113-10, 41-66004-10, 41-66011-10, 42-61286-10, 42-61286-10, 42-63406-10, 42-65107-10, 42-65114-10, 42-65121-10, 42-66005-10, 43-63319-10, 43-64312-10, 43-65041-10, 43-65041-10, 43-65115-10, 43-66006-10, 43-66013-10, 43-66101-10, 44-51494-10, 44-65042-10, 44-65123-10, 44-65130-10, 44-65204-10, 44-66007-10, 44-66014-10, 44-66021-10, 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  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA (AR, CA, FL, KY, LA, MA, NE, OH, PA, SC, SD, TN, and UT) and countries of Australia, Austria, Canada, Czech Republic, Finland, France, Israel, Italy, New Zealand, Spain, Switzerland, and Sweden.
  • Product Description
    Battery Caps used with Animas IR1200 Insulin Pump. || The pump is used to help maintain blood glucose targets.
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • Manufacturer Address
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA