BEUDAMED
    FDA Recall Terminated

    Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module

    Recall: Z-0492-2011 · Initiated August 2, 2010

    Recall

    Recall Number
    Z-0492-2011
    Event Number
    56405
    Firm
    CareFusion Corporation
    FEI Number
    2016493
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 2, 2010
    Terminated
    July 25, 2013
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121

    Description

    Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module

    Reason

    Than recall was initiated because CareFusion has identified identified a potential risk associated with the Alaris PC unit formerly known as Medley PC unit (PC Unit) model 8000 only when used with Alaris Pump module (Pump module) or Alaris Syringe module' (Syringe module), This recall notification details the potential risk and recommended steps for users to take if they encounter a specific PC

    Action

    CareFusion will send by registered return receipt mail the customer notification letter to all customers using the affected Alaris PC Unit beginning August 24, 2010. The customer notification letter will be addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering. Customers will be required to confirm receipt of the notification by returning the Recall Response Card to CareFusion by postage-paid, selfaddressed mail, fax or email. The recall notice informed the customers of the reason for the notice, the units affected, the potential risk, a step-by-step description of the issue and the required actions for users. The customers were also told that CareFusion is working to release a software update to address this display error and will contact your facility as soon as the software update is available. CareFusion does not require that you return your devices. Clinicians should weigh the risk/benefits to the patients before continuing the use of the device. Customers were also told that any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program. The recall notice provided contact information for CareFusion's Recall Center, Customer Advocacy and Technical Support units.

    Distribution

    Nationwide in the United States, Canada, Mexico, and the European Union

    Quantity

    94,146 units