Events

Recall of Device Recall Infusion Pump Intermate Infusion Pump

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

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
    65365
  • Event Risk Class
    Class 2
  • Event Number
    Z-1604-2013
  • Event Initiated Date
    2013-06-07
  • Event Date Posted
    2013-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119107
  • 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 - Product Code FRN
  • Reason
    Baxter healthcare corporation (baxter) is issuing an urgent product recall for the products listed above due to an increase in rupture complaints. baxter has implemented product and process improvements which have substantially improved product quality. complaint rates for ruptures have since decreased. baxter wants to ensure that no affected product remains in the field.
  • Action
    An Urgent Product Recall notification was sent to all affected consignees on 06/13/2013. The letter states the affected products, problem description, hazard involved and actions to be taken by customer/user, with contact information. The letter was accompanied by a Customer Reply Form and a table of Affected Product List. The recall notification instructs customers to segregate affected product and contact Baxter for instructions for return of product.

Device

Device Recall Infusion Pump Intermate Infusion Pump
  • Model / Serial
    Product Codes: 2C1730K, 2C1732K, 2C1734K, 2C1740K, 2C1743K, 2C1744K  Lot Codes: 10F009 10F049 10F053 10F057 10F095 10J006 10J079 10K077 10M067 10F004 10F015 10G016 10G017 10G018 10G019 10G053 10G054 10H007 10H008 10H009 10H049 10H050 10H051 10H079 10H080 10H081 10H108 10J002 10J009 10J011 10J012 10J077 10J078 10J083 10K009 10K010 10K011 10K012 10K014 10K018 10K070 10K071 10K072 10M015 10M061 10M066 10M071 10M073 10M074 10M082 10F010 10F011 10F079 10G021 10G022 10G023 10H010 10H025 10H026 10H047 10J003 10J004 10J005 10J080 10J081 10J082 10J093 10K016 10K017 10K019 10M008 10M010 10M075 10M078 10M080 10M081 10H083 10M065 10F051 10F073 10G039 10G040 10J007 10J008 10J109 10K007 10K057 10K106 10M064 10M070 10F005 10F006 10F052 6/19/2010  6/22/2010  6/23/2010  8/13/2010  8/23/2010  8/30/2010  9/3/2010  9/30/2010  10/4/2010  10/21/2010  10/26/2010  11/4/2010  11/15/2010  11/24/2010   Expiration Date: 06/30/13
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide and in Puerto Rico.
  • Product Description
    Brand Name: Intermate Infusion Pump. || Indicated for the intravenous administration of medications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Route 120 And Wilson Rd, Round Lake IL 60073-9799
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA