BEUDAMED
    FDA Recall Terminated

    Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").

    Recall: Z-1486-2014 · Initiated April 14, 2014

    Recall

    Recall Number
    Z-1486-2014
    Event Number
    68041
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 14, 2014
    Posted
    April 22, 2014
    Terminated
    July 17, 2014
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    Description

    Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").

    Reason

    Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA3

    Action

    Customers were notified on 4/14/14 via certified letter with instructions to identify product, discontinue use, and return products.

    Distribution

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

    Quantity

    186