Events

Recall of Device Recall Alaris Medley Pump Module

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
    47335
  • Event Risk Class
    Class 2
  • Event Number
    Z-1710-2008
  • Event Initiated Date
    2008-03-05
  • Event Date Posted
    2008-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69241
  • 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
    A channel error on an affected alaris system module will stop an active infusion (or monitoring) with an audible and visual alarm. channel errors due to failures of the u19 socketed integrated circuits (u19 ic) on the logic board of the alaris pump module ("pump module"). the user will be required to replace the affected module.
  • Action
    An Urgent Medical Device Recall Notification letter was sent to consignees on April 10, 2008. Four customer letters were issued. The U19 IC issue affects only the Pump module and the U9 IC issue affects only the Syringe and PCA modules. Therefore there will be one letter for customers affected by all three issues Ul9 IC, U9 IC, and the IUI, one letter for affected Ul9 IC and U9 IC customers, one letter for U19 IC-only customers and one letter for U9 IC-only customers. All mailings were conducted through consignees (distributors as well as direct customers for the affected devices). Distributors will be sent multiple copies of the Recall Notification and Customer Response Cards. The Recall letters all includeRequired Actions sections which give their customers specific information about the issue and what the customers are to do and includes a web site link for each specific problem. Each recall letter also has chart of Cardinal Health contacts support.

Device

Device Recall Alaris Medley Pump Module
  • Model / Serial
    Pending
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- USA including states of AR, AZ, CA, CT, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI and WY, Guam and country of Canada. ****CDRH Comments: "Note for District Office to follow-up" The firm has not provided a grand total of devices affected by these problems. It is possible that devices suffering from U19 & U9 problems may also experience IUI problems. This recall has 3 problems with 6 modules. One problem affects only 2 modules, one problem affects 6 modules. For simplicity and expediency, CDRH agrees to keep the file as is, rather than separate into 6 products and have complicated explanations of the problems. 77,515 devices affected by IUI problem. 85,286 devices affected by U19 problem. 8,286 devices affected by U9 problem. ****
  • Product Description
    U19 Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules (aka. Medley Pump modules), Model 8100 built on or before September 8, 2005. CardinalHealth, San Diego, CA 92130
  • 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