BEUDAMED
    FDA Recall Terminated

    NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire

    Recall: Z-1345-2016 · Initiated November 3, 2015

    Recall

    Recall Number
    Z-1345-2016
    Event Number
    72957
    Firm
    AngioDynamics Inc.
    FEI Number
    3017892510
    Product Code
    OEZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 3, 2015
    Posted
    April 7, 2016
    Terminated
    March 16, 2017
    Address
    10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864

    Description

    NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT, REF Catalog No. 60080094, UPN Product No. H749600800941 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire

    Reason

    Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036".

    Action

    On November 03, 2015, Navilyst Medical distributed Urgent Voluntary Medical Device Recall notices to their customers via courier service. Customers were advised to immediately remove the recall product from inventory and to segregate the products in a secure location for return to AngioDynamics, Inc. Customers should immediately forward a copy of the recall notification letter to all sites if these products were further distributed. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday - Friday EST) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return). The Reply Verification Tracking form can be submitted via fax to: Attn: Convenience Kits - Procedure Products Needles 1-800-782-1357 or via email to [email protected] or [email protected].

    Distribution

    US Nationwide in the states of CA, IL, MA, SC, TX

    Quantity

    8 kits