BEUDAMED
    FDA Recall Terminated

    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.

    Recall: Z-0814-2016 · Initiated January 15, 2016

    Recall

    Recall Number
    Z-0814-2016
    Event Number
    73093
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    BRY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 15, 2016
    Posted
    February 16, 2016
    Terminated
    May 8, 2017
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients.

    Reason

    Customers reported issues when scanning medications with the scanners. When a user scans a medication using the affected barcode scanner, information on a different medication could be communicated to the Pyxis product.

    Action

    BD sent an Urgent Medical Device Recall Notification letter dated January 15, 2015 to all affected customers The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete the enclosed Customer Response Card by selecting the desired deployment option and return the card to CareFusion. Customers with questions are instructed to contact the CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact CareFusion Customer Advocacy at (800) 836-7842. Customers with technical questions are instructed to contact CareFusion Technical Support at (800) 727-6102.

    Distribution

    Worldwide:Distribution - US Nationwide and the countries of Saudi Arabia, Bahrain, Australia, United Arab Emirates, Qatar, Mexico, Guam and the Bahamas.

    Quantity

    9,345 units