BEUDAMED
    FDA Recall Terminated

    Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

    Recall: Z-0691-2017 · Initiated July 29, 2016

    Recall

    Recall Number
    Z-0691-2017
    Event Number
    75291
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    LRS
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    July 29, 2016
    Terminated
    March 6, 2018
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

    Reason

    Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.

    Action

    BBMI (B. Braun) provided written notification on August 05, 2016, to all BBMI customers in receipt of the suspected product. These customers included both BBMI direct end customers and BBMI direct distributors. Customers were asked to determine if they had the affected lots in their possession. If they did, customers were asked not to destroy the product and to immediately discontinue use of and quarantine if found. Customers were also asked to complete the Product Removal Acknowledgement form and return to B. Braun. B. Braun will contact each customer if they have any full cases, partial cases or unused pieces of the affected products to provide instructions for handling and return of the affected products. Customers with questions were instructed to call 1-800-227-2862.

    Distribution

    Nationwide Distribution to GA, IL, and FL

    Quantity

    15,950 units