Events

Recall of Device Recall Alaris PCA Module and Alaris PC Unit with software versions 8 thourh 9.1

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

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
    51432
  • Event Risk Class
    Class 2
  • Event Number
    Z-1237-2009
  • Event Initiated Date
    2009-03-04
  • Event Date Posted
    2009-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80264
  • 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
    The alaris pca module can potentially infuse above or below the intended infusion dose.
  • Action
    The field action was initiated on March 11, 2009 with Cardinal Health sending by registered return receipt mail a Safety Alert to all customers using the Alaris PC Unit with software versions 8 through 9.1, which encompasses the subset of those customers that use the Alaris PCA Module. The Safety Alert was addressed to the Directors of Nursing, Pharmacy, Risk Management, and Biomedical Engineering at each hospital facility. If a customer did not respond to the Safety Alert, then Cardinal Heath notified that customer by telephone to verify receipt of the Safety Alert. This Safety Alert Informed the customers about a potential risk, and required them to: (1) Determine whether you use version 8 through 9.1 of the Alaris PC Unit. (2) Forward this Safety Alert to all Data Set owners (3) To immediately identify the potential risks review enclosed FAQs and Instructions for Data Set Review. (4)Continue to follow the Institute for Safe Medication Practices (ISMP) and the Joint Commission recommendation for safe medication administration - two nurses checking to ensure that the correct prescription is being entered into the PCA pump when first ordered and when there are any changes in the prescription (paying close attention to dosing units and infusion modes). The customers were also instructed to call our Support Center at 1-888-562-6018 with any questions. An updated Customer Recall Notification was forwarded by registered return receipt mail by Cardinal Health on April 15,2009. This notice reinforced the information in the first notice in addition to informing the customers of the hazard of an over-infusion or under-infusion of medication. Also, customers were given instruction for reporting any adverse reactions experienced with the use of the affected product and/or quality problems via the FDA's MedWatch Program.

Device

Device Recall Alaris PCA Module and Alaris PC Unit with software versions 8 thourh 9.1
  • Model / Serial
    software versions 8 through 9.1. Serial Numbers: 000000000003692805, 000000000002326369 to 000000000012892953.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Germany, Malaysia, and Singapore.
  • Product Description
    Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1.
  • Manufacturer
    Cardinal Health 303 dba Cardinal Health

Manufacturer

Cardinal Health 303 dba Cardinal Health
  • Manufacturer Address
    Cardinal Health 303 dba Cardinal Health, 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA