Events

Recall of Device Recall ALARIS PC UNIT

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
    52119
  • Event Risk Class
    Class 1
  • Event Number
    Z-1791-2009
  • Event Initiated Date
    2009-06-12
  • Event Date Posted
    2009-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82142
  • 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
    Affected unit: alaris pc unit (models 8000 and 8015) with software a versions 8 and above when used with the alaris pca module (model 8120) there is a potential risk of over infusion related to a warning message on the user interface of the alaris pc unit when used in conjunction with the alaris pca module. when the alaris pc unit detects a programmed infusion for the alaris pca module that exceed.
  • Action
    The recall was initiated on June 12, 2009 with the firm forwarding via UPS an Urgent: Medical Device Recall Notification with attached Customer Response Card to the Chief Administrative Officer, Director of Pharmacy, Director of Biomedical Engineering, Director of Nursing & Director of Risk Management of all of the affected consignees. Customers were also asked to please promptly complete and return the enclosed Customer Response Card to expedite the correction process. The Recall Notification informed the consignees of: (A) PROBLEM #1: Occlusion Warning Message for Alaris Pump Module; (B) PROBLEM #2 Syringe volume Warning Message for Alaris PCA module; (C) PROBLEM #3 Electrostatic Discharge (ESD) protection circuitry; (D) PROBLEM #4 Fluid Ingress and (E) PROBLEM #5 Alaris System Inter-Unit Interface (IUI) Connectors Labeling. The recall notice included "Required Action for Users & Follow-up actions by Cardinal Health for all five problems. Customers were also asked to report any adverse reactions experienced with the use of this product, and/or quality problems to the FDA's MedWatch Program. In addition, customer were provided the following contact information for the recall: (1) Cardinal Health Recall Center for general questions: By phone at 1-888-562-6018 7am to 5pm (Pacific) ; (2) Customer Advocacy for adverse reports: By phone at 1-800-854-7120, Option 1, Option 1, Option 3 or by email at customerfeedback@cardinalhealth.com 24 hours a day, Sunday-Saturday; (3) Technical Support for Technical Questions regarding the Alaris System: By phone at 1-888-562-6018, 6am-5pm (Pacific). The firm followed-up with the release of a nationwide press statement regarding this issue on July 29, 2009. The press release indicated serial numbers of affected devices, as well as CareFusions short term instructions to customers, and the firms strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/ (This informatio

Device

Device Recall ALARIS PC UNIT
  • Model / Serial
    Model Numbers 8000 and 8015 software version 8 and above when used with the Alaris PCA Module (Model 8120).
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (including Puerto Rico and Guam), Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand.
  • Product Description
    The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120). || The Alaris PC Unit is the central programming and power supply component for the Alaris System modules.
  • 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