Events

Recall of Device Recall Model 8100 Series Medley Medication Safety System Pump Module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alaris Medical Systems 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
    30451
  • Event Risk Class
    Class 2
  • Event Number
    Z-0568-05
  • Event Initiated Date
    2004-11-10
  • Event Date Posted
    2005-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35916
  • 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
    The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. to date there have been complaints from three (3) different customer locations.
  • Action
    A device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module.

Device

Device Recall Model 8100 Series Medley Medication Safety System Pump Module

Manufacturer

Alaris Medical Systems Inc
  • Manufacturer Address
    Alaris Medical Systems Inc, 10221 Wateridge Cir, San Diego CA 92121-2733
  • Source
    USFDA