BEUDAMED
    FDA Recall Terminated

    NIPRO Safe Touch Safety Scalp Vein Set

    Recall: Z-1834-2014 · Initiated May 4, 2013

    Recall

    Recall Number
    Z-1834-2014
    Event Number
    65274
    Firm
    Nipro Medical Corporation
    FEI Number
    1000132332
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 4, 2013
    Posted
    June 19, 2014
    Terminated
    March 2, 2015
    Address
    3150 Nw 107th Ave, Miami, FL, 33172

    Description

    NIPRO Safe Touch Safety Scalp Vein Set

    Reason

    There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.

    Action

    Nipro sent a Recall Notification letter dated April 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall does extend to the customer level. Please notify all customers of the recall and collect all affected product that is in their possession. When all products have been received from your customers call tags and RMAs will be issued in order for you to return all products to Nipro Medical warehouse in Memphis TN. You will then be reimbursed for all products received. Please place all products you have in stock on hold. Use the attached faxback to respond to this notification, with product codes, lots and quantities you have in all of your distribution facilities. One form should be completed for each distribution location. Return forms as soon as possible to Nipro Medical, fax: 305.592.4621. Any questions or concerns can be addressed by phone at 305.599.7174 ext. 249.

    Distribution

    Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.

    Quantity

    176,000 pieces