BEUDAMED
    FDA Recall Terminated

    Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.

    Recall: Z-0187-2016 · Initiated August 25, 2015

    Recall

    Recall Number
    Z-0187-2016
    Event Number
    72052
    Firm
    Resource Optimization & Innovation Llc
    FEI Number
    3004513970
    Product Code
    LHC
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    August 25, 2015
    Posted
    October 30, 2015
    Terminated
    April 6, 2017
    Address
    2909 N Neergard Ave, Springfield, MO, 65803

    Description

    Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.

    Reason

    Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.

    Action

    On August 25, 2015, the recalling firm sent an email to their direct customers informing them of the recall. The email instructed their customers to examine their inventory and determine whether they had any of the affected devices. The recalling firm attached the recall notice they received from their supplier. On September 4, 2015, the recalling firm sent a second email clarifying that they were instructing their customer to discard the supplier component . The notice also asked the customer to respond with how many affected devices they had in their inventory at the time they received the notice.

    Distribution

    Distributed in Texas and Louisiana.

    Quantity

    153 kits