BEUDAMED
    FDA Recall Terminated

    Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222

    Recall: Z-0966-2019 · Initiated December 20, 2018

    Recall

    Recall Number
    Z-0966-2019
    Event Number
    82019
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    3000204839
    Product Code
    OEZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 20, 2018
    Terminated
    August 20, 2019
    Address
    125 Blue Ball Rd, Elkton, MD, 21921-5315

    Description

    Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222

    Reason

    Presence of natural rubber latex is not declared in the label

    Action

    Terumo issued Urgent Medical Device Recall dated 12/20/18 stating reason for recall, health risk and an appropriate course of action for the return of affected product to Terumo. Questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET.

    Distribution

    TX

    Quantity

    12 packs