BEUDAMED
    FDA Enforcement Class I Terminated

    HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

    Recall: Z-1048-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1048-2014
    Event ID
    66080
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 5, 2014
    Initiation Date
    August 14, 2013
    Classification Date
    February 21, 2014
    Termination Date
    December 19, 2017
    Address
    1170 S Northpoint Blvd, Waukegan, IL, 60085-6757, United States

    Description

    HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.

    Reason

    Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of the wire. The guidewire is used in a number of surgical convenience kits assembled and marketed by Medline Industries, Inc.

    Code Info

    Pack Number: DYNJ39747A; Lots: 13EB2095, 13EB3153, 13FB4157, 13RB0832, 13GB2692

    Distribution

    Nationwide Distribution: US to states of: AL, CA, FL, IL, LA, OH and VA.

    Quantity

    160 units