BEUDAMED
    FDA Recall Terminated

    V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538

    Recall: Z-2223-2011 · Initiated April 5, 2011

    Recall

    Recall Number
    Z-2223-2011
    Event Number
    58514
    Firm
    Neo Medical, Inc.
    FEI Number
    2925153
    Product Code
    LRS
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    April 5, 2011
    Posted
    May 19, 2011
    Terminated
    November 22, 2011
    Address
    42514 Albrae St., Fremont, CA, 94538

    Description

    V-CATH Insertion Kits, Sterile; Product Code Number: 301-00; Manufactured by Centurion Medical Products for Neo Medical; 42514 Albrae Street, Fremont, CA 94538

    Reason

    Firm received recall notice from their contract manufacturer due to visible particulates in Bacteriostatic Sodium Chloride Injection, USP 0.9%, 30 mL vials that are included in insertion kits.

    Action

    Neo Medical forwarded Urgent Recall Notices to Dealers and customers on April 5, 2011 via fax. Neo Medical Customer Care also contacted customers by phone on April 7, 2011, followed by Urgent Product Recall Notification letters were sent on April 11, 2011 along with a copy of the Recall Notification from Centurion. The letter requested that customers with affected lots immediately discontinue distribution and contact the end users instructing them to stop dispensing the product. Customers were to complete the accountability information even if inventory had been depleted and fax it to 510-353-9025. In order to return the affected product, customers should contact the Complaint Coordinator at 925-719-2197 or [email protected]. Replacement or credit would be issued for all product returned.

    Distribution

    Worldwide Distribution -- USA, including states of MO, WA, PA, CA, OH, UT, TX and Canada.

    Quantity

    1990