BEUDAMED
    FDA Enforcement Class II Terminated

    Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn

    Recall: Z-1647-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1647-2017
    Event ID
    76255
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Resource Optimization & Innovation Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 5, 2017
    Initiation Date
    January 9, 2017
    Classification Date
    March 24, 2017
    Termination Date
    September 28, 2018
    Address
    2909 N Neergard Ave, Springfield, MO, 65803-6317, United States

    Description

    Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn

    Reason

    Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

    Code Info

    034408E Exp Date 2018-04-30; 038488E Exp Date 2018-06-30; 039730E Exp Date 2018-08-30

    Distribution

    US Distribution to LA and TX.

    Quantity

    228 kits