BEUDAMED
    FDA Enforcement Class II Terminated

    Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").

    Recall: Z-1485-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1485-2014
    Event ID
    68041
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2014
    Initiation Date
    April 14, 2014
    Classification Date
    April 22, 2014
    Termination Date
    July 17, 2014
    Address
    1600 West Merit Parkway, N/A, South Jordan, UT, 84095, United States

    Description

    Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").

    Reason

    Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling.

    Code Info

    Lot No. K556399, Expires 2016-10

    Distribution

    Worldwide Distribution: USA Nationwide and China. No military/govt/VA consignees.

    Quantity

    173