Events

Recall of Alaris SE Pump (formerly Signature Edition Infusion Pump)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health 303 Inc DBA Alaris Products.

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
    36064
  • Event Risk Class
    Class 1
  • Event Number
    Z-1484-06
  • Event Initiated Date
    2006-08-10
  • Event Date Posted
    2006-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47889
  • 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
    infusion pump - Product Code FRN
  • Reason
    This recall was initiated because of a potential for over infusion with all models of the alaris¿ se pumps (formerly the signature edition¿ infusion pumps) caused by key bounce.
  • Action
    Corrective action for this recall will include notifications (five letters) being sent (Return Receipt) to all customers with affected product alerting them to this action. The letters are addressed to the Director of Biomedical Engineering, Director, Materials Management, Hospital Administration, Purchasing, and the fifth letter to the Director of Nursing. The August 15, 2006, recall letters and the warning labels will be sent return receipt requested. The verification of receipt of the notifications will be tracked and return receipt exceptions will be followed up. Follow up activities will be documented including customer contact.

Device

Alaris SE Pump (formerly Signature Edition Infusion Pump)
  • Model / Serial
    Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232. (ALL MODELS, ALL LOTS)  The serial numbers are not sequential.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and American Samoa, Guam, and Puerto Rico. Worldwide.
  • Product Description
    Alaris¿ SE Pump (formerly Signature Edition¿ Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232
  • Manufacturer
    Cardinal Health 303 Inc DBA Alaris Products

Manufacturer

Cardinal Health 303 Inc DBA Alaris Products
  • Manufacturer Address
    Cardinal Health 303 Inc DBA Alaris Products, 10221 Wateridge Cir, San Diego CA 92121-2733
  • Source
    USFDA