BEUDAMED
    FDA Enforcement Class II Terminated

    Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.

    Recall: Z-0229-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0229-2016
    Event ID
    72053
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Resource Optimization & Innovation Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 11, 2015
    Initiation Date
    August 25, 2015
    Classification Date
    November 5, 2015
    Termination Date
    April 6, 2017
    Address
    2909 N Neergard Ave, N/A, Springfield, MO, 65803, United States

    Description

    Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.

    Reason

    The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.

    Code Info

    Lot 25787E, exp. date 1/19/2017

    Distribution

    Product was distributed to one customer in Oklahoma.

    Quantity

    255 packs