BEUDAMED
    FDA Recall Terminated

    BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.

    Recall: Z-0834-2010 · Initiated October 19, 2009

    Recall

    Recall Number
    Z-0834-2010
    Event Number
    53749
    Firm
    Becton Dickinson Medical Systems
    FEI Number
    1710034
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 19, 2009
    Posted
    February 2, 2010
    Terminated
    October 19, 2010
    Address
    9450 S State St, Sandy, UT, 84070-3213

    Description

    BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc.

    Reason

    Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.

    Action

    Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=

    Distribution

    Nationwide distribution.

    Quantity

    1,021,600 units