Events

Recall of Device Recall Alaris Pump Module model 8100

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

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
    77279
  • Event Risk Class
    Class 2
  • Event Number
    Z-2700-2017
  • Event Initiated Date
    2017-06-12
  • Event Date Posted
    2017-06-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155608
  • 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
    There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the alaris pump module model 8100.
  • Action
    An Urgent Medical Device Recall letter will be sent on 6/12/17 to customers to inform them that BD is issuing this letter to inform you of a potential risk associated with the Alaris Pump module. Firm identified a specific scenario that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. This scenario is reproducible under the following situations: a) the user does not close the roller clamp on the IV administration set before the pump door is opened as recommended, and b) opening the pump door using an atypical technique with the door latch with the centered sear design. The letter instructs customers If their device has a centered-sear that was manufactured between June 2002 to June 2004, clearly mark and sequester (e.g. Biomed department) the Alaris Pump module that exhibited the issue. Notify CareFusion Customer Advocacy at 888-812-3266 or customerfeedback@carefusion.com to coordinate an onsite remediation or send the devices to the BD Service Depot.

Device

Device Recall Alaris Pump Module model 8100
  • Model / Serial
    Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and Canada
  • Product Description
    Alaris Pump Module model 8100
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • Manufacturer Address
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA