BEUDAMED
    FDA Recall Terminated

    Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.

    Recall: Z-2327-2012 · Initiated June 29, 2012

    Recall

    Recall Number
    Z-2327-2012
    Event Number
    62774
    Firm
    C.R. Bard, Inc., Urological Division
    FEI Number
    1018233
    Product Code
    EZC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 29, 2012
    Posted
    September 7, 2012
    Terminated
    February 7, 2013
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.

    Reason

    Incomplete seal on sterile packages of product.

    Action

    C. R. Bard Inc, sent a Urgent Product Recall Notification letter dated June 27. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notification is being sent because there is a potential for a limited number of units within the subject lots (noted above) that may contain an open seal of the sterile packages. The issue is visually obvious even before the package is opened. No patient injury or adverse events have been reported. Do not use or further distribute any of the affected products. Once the product affected by tlle recall has been removed from your inventory 1.Fill out the Recall & Effectiveness Check Form. Be sure to state the quantities affected of the recalled product that you have in stock. It is extremely important that we receive this information. 2. Fax the Recall & Effectiveness Check Form to BMD at 1-770-784-6469. The Recall Coordinator will issue you with a Return Authorization (RCL) to facilitate the expedient return and replacement of the product. 3. A mailing label is enclosed for your convenience to return the affected product. Please mark the outside package as "RECALLED PRODUCT" and include the RCL number. All products should be retumed to the following shipping address that is in the letter.

    Distribution

    Nationwide distribution: USA

    Quantity

    56,694 units