Events

Recall of Baxter Healthcare

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
    70641
  • Event Risk Class
    Class 2
  • Event Number
    Z-1536-2015
  • Event Initiated Date
    2014-04-17
  • Event Date Posted
    2015-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134369
  • 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, pca - Product Code MEA
  • Reason
    Potential for device malfunction resulting in flow when the device should not be flowing.
  • Action
    Baxter Healthcare sent an Urgent Product Recall letter dated April 17, 2014, to the sole US consignee. The letter included instructions for the consignee to: 1) locate and remove all affected product; 2) contact Baxter's Center for Service to arrange for the return and credit; and 3) to complete and return the Customer Reply Form included with the recall notification. Questions about the recall can be answered by calling The Center for One Baxter at 800-422-9837.

Device

Baxter Healthcare
  • Model / Serial
    1) Product Code: 2C1067; Lots and Expiration Dates: Lot 11D001 , Expires 4/1/2014 ; Lot 11D068 , Expires 4/1/2014 ; Lot 11E048 , Expires 5/1/2014 ; Lot 11E084 , Expires 5/1/2014 ; Lot 11F050 , Expires 6/1/2014 ; Lot 11G019 , Expires 7/1/2014 ; Lot 11H019 , Expires 8/1/2014 ; Lot 11H074 , Expires 8/1/2014 ; Lot 11J042 , Expires 9/1/2014 ; Lot 11J078 , Expires 9/1/2014 ; Lot 11M078 , Expires 11/1/2014 ; Lot 11N027 , Expires 12/1/2014 ; Lot 12A020 , Expires 1/1/2015 ; Lot 12A037 , Expires 1/1/2015 ; Lot 12A050 , Expires 1/1/2015 ; Lot 12A095 , Expires 2/1/2015 ; Lot 12B040 , Expires 2/1/2015 ; Lot 12C033 , Expires 3/1/2015 ; Lot 12D016 , Expires 4/1/2015 ; Lot 12D041 , Expires 4/1/2015 ; Lot 12D089 , Expires 4/1/2015 ; Lot 12E004 , Expires 5/1/2015 ; Lot 12F010 , Expires 6/1/2015 ; Lot 12F036 , Expires 6/1/2015 ; Lot 12G032 , Expires 7/1/2015 ; Lot 12G034 , Expires 7/1/2015 ; Lot 12G057 , Expires 7/1/2015 ; Lot 12H012 , Expires 7/1/2015 ; Lot 12H033 , Expires 8/1/2015 ; Lot 12H077 , Expires 8/1/2015 ; Lot 12J047 , Expires 9/1/2015 ; Lot 12K008 , Expires 10/1/2015 ; Lot 12M036 , Expires 11/1/2015 ; Lot 12N031 , Expires 12/1/2015 ; Lot 13A016 , Expires 1/1/2016 ; Lot 13A084 , Expires 1/1/2016 ; Lot 13B037 , Expires 2/1/2016 ; Lot 13C018 , Expires 3/1/2016 ; Lot 13D012 , Expires 4/1/2016 ; Lot 13E009' , Expires 5/1/2016 ; Lot 13E034' , Expires 5/1/2016 ; Lot 13F044 , Expires 6/1/2016 ; Lot 13F058 , Expires 6/1/2016 ; Lot 13G026 , Expires 7/1/2016 ; Lot 13H025 , Expires 8/1/2016 ; Lot 13H081 , Expires 8/1/2016 ; Lot 13J007 , Expires 9/1/2016 ; Lot 13M052 , Expires 11/1/2016 ; Lot 13N008 , Expires 12/1/2016 ; Lot 14A019 , Expires 1/1/2017 ; Lot 14A033 , Expires 1/1/2017 ; Lot 14B015 , Expires 2/1/2017 ;   2) Product Code: 2C1067K; Lots and Expiration Dates: Lot 11E025 , Expires 5/31/2014 ; Lot 11H035 , Expires 8/31/2014 ; Lot 11N025 , Expires 12/31/2014 ; Lot 12D061 , Expires 4/30/2015 ; Lot 12F012 , Expires 6/1/2015 ; Lot 12K024 , Expires 10/31/2015 ; Lot 13A047 , Expires 1/31/2016 ; Lot 13H067 , Expires 8/31/2016 ; Lot 13N025 , Expires 12/31/2016 ; Lot 13N026 , Expires 12/31/2016 ; Lot 13N027 , Expires 12/31/2016 ; Lot 13N045 , Expires 12/31/2016
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the state of FL., and to the countries of : Belgium, Denmark, Germany, Italy, Japan, Norway, Poland, South Korea, Spain, Sweden and United Arab Emirates.
  • Product Description
    The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA