BEUDAMED
    FDA Recall Terminated

    Material ECVC575, MULTI-LUMEN CVC TRAY, CENTURION HURON MED CTR MULTI-LUMEN CVC TRAY, REORDER ECVC575, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE INSERTION

    Recall: Z-2368-2011 · Initiated March 31, 2011

    Recall

    Recall Number
    Z-2368-2011
    Event Number
    58346
    Firm
    Centurion Medical Products Corporation
    FEI Number
    3008403546
    Product Code
    LRS
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    March 31, 2011
    Posted
    May 27, 2011
    Terminated
    September 13, 2011
    Address
    100 Centurion Way, Williamston, MI, 48895-9086

    Description

    Material ECVC575, MULTI-LUMEN CVC TRAY, CENTURION HURON MED CTR MULTI-LUMEN CVC TRAY, REORDER ECVC575, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE INSERTION

    Reason

    This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9% utilized to make the products may contain visible particulates.

    Action

    Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits. Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession. Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account. For any questions regarding this recall call 631-924-4000, ext 142.

    Distribution

    Nationwide Distribution

    Quantity

    30