Events

Recall of SPECTRUM 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
    69122
  • Event Risk Class
    Class 2
  • Event Number
    Z-2738-2014
  • Event Initiated Date
    2014-09-03
  • Event Date Posted
    2014-10-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129683
  • 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
    One service technician may not have correctly serviced specific sigma spectrum infusion pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.
  • Action
    Initial notification was initiated via telephone call by the Baxter Medina Service Center on 8/28/14 to all affected Sigma SPECTRUM Infusion Pump consignees. URGENT DEVICE CORRECTION Letters (dated 9/03/2014) were sent to the consignees via USPS first class mail on 9/03/14 formally informing them of the recall. The letters identified the affected product, the description of the issue, the hazard involved, as well as, the actions to be taken by customer. Customers are being instructed to immediately remove the pump from use and return the pump to Baxter for inspection. The firm will provide replacements. Customers are to contact Baxter Healthcare Medina at 800-356-3454 for technical questions regarding the letter.

Device

SPECTRUM Pump
  • Model / Serial
    Software Versions 5.02.06, 6.02.06, and 6.02.11; Affected Serial Numbers: 712090, 723687, 723842, 724966, 725820, 735977, 751130, 752124, 755174, 768538, 771990, 774743, 781406, 783736, 784698, 794466, 805797, 808901, 809113, 812462, 815932, 842120, 857926, 858672, 862085, 863721, 865630, 873459, 889597, 890260, 903748, 912619, 920574, 920589, 956346, 957394, 965402, 966684, 976931, 977550, 978361, 983979, 984066, 984129, 984475, 985946, 987538, 993445, 995291, 996014, 996389, 1013037, 1004377, 1014565, 1014962, 967887, 950671, and 938428.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    SPECTRUM Pump, Model No. 35700BAX. || Intended to be used for the controlled administration of intravenous fluids.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., 25212 W. Illinois Route 120, Round Lake IL 60073-9799
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA