BEUDAMED
    FDA Recall Terminated

    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

    Recall: Z-1996-2014 · Initiated March 28, 2014

    Recall

    Recall Number
    Z-1996-2014
    Event Number
    68552
    Firm
    RGI Medical Manufacturing, Inc.
    FEI Number
    3004994611
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 28, 2014
    Posted
    July 7, 2014
    Terminated
    September 29, 2016
    Address
    4637 NW 6th St, Gainesville, FL, 32609-0701

    Description

    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

    Reason

    Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.

    Action

    RGI Medical Manufacturing, Inc. phoned their direct account: Baxter Healthcare on February 28, 2014 and sent an Urgent: Device Recall letter dated March 21, 2014. The letter identified the affected product, problem and the actions to be taken. Contact 800-747-6870 to obtain instruction for returning the product to RGI

    Distribution

    US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.

    Quantity

    19,200 units.