BEUDAMED
    FDA Enforcement Class II 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 · Reported September 19, 2012

    Enforcement

    Recall Number
    Z-2327-2012
    Event ID
    62774
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc., Urological Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    September 19, 2012
    Initiation Date
    June 29, 2012
    Classification Date
    September 7, 2012
    Termination Date
    February 7, 2013
    Address
    8195 Industrial Blvd Ne, N/A, Covington, GA, 30014-1497, United States

    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.

    Code Info

    Catalog No. 300316A (Lot Nos. - NGVJ1108, NGVJ1712, NGVJ1713, NGVJ1105, NGVJ1714) Catalog No. 898316 (Lot Nos. NGVJ1614, NGVJ1615, NGVJ1616, NGVJ1617) Catalog No. 897414 (Lot No. NGVJ1705) Catalog No. 907618 (Lot No. NGVJ1757) Catalog No. 907600 (Lot No. NGVJ1764)

    Distribution

    Nationwide distribution: USA

    Quantity

    56,694 units