BEUDAMED
    FDA Recall Terminated

    26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550

    Recall: Z-2343-2018 · Initiated June 4, 2018

    Recall

    Recall Number
    Z-2343-2018
    Event Number
    80231
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 4, 2018
    Terminated
    January 13, 2020
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    26-Lead Transfer Set for use with APEX Compounding System, Product Catalog Number 2112550

    Reason

    There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there is potential for unintended admixture.

    Action

    Urgent Medical Device Correction - Recall Notification letters were distributed on 6/4/18. The letters instruct customers to perform the following: 1. Review this Medical Device Correction Notification in its entirety and ensure that all users of the above mentioned products in your organization and other concerned persons are informed about this medical device correction - recall notification. If you are a distributor, please forward this recall notification to your customers. 2. Perform a visual inspection of valve orientation prior to installation onto APEX Compounding System in accordance with the Visual Inspection Instructions contained in Attachment 1. 3. If any misaligned valves are identified, do not use the transfer set. Please contact Customer Support at 1-800-227-2862 for product return and replacement. 4. Utilizing the attached "Medical Device Correction - Recall Notification Acknowledgement" form, please acknowledge that you have received and reviewed this information. 5. Return the completed "Medical Device Correction - Recall Notification Acknowledgement" form to B. Braun Medical Inc Quality Assurance department by faxing or e-mailing the form within two (2) weeks of receipt of this notice. It is important this form is returned to B. Braun Medical Inc can meet regulatory requirements of the United States Food and Drug Administration.

    Distribution

    The products were distributed to the following US states: AL, CA, CO, CT, FL, GA, IL, LA, MA, MD, MI, MN, MO, NC, NJ, NV, OH, PA, TX, and WA.

    Quantity

    12320