BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    Recall: Z-0797-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0797-2013
    Event ID
    64084
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Custom Healthcare Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2013
    Initiation Date
    November 26, 2012
    Classification Date
    February 7, 2013
    Termination Date
    February 8, 2013
    Address
    4205 Eubank Rd, N/A, Richmond, VA, 23231-4328, United States

    Description

    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    Reason

    Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.

    Code Info

    LOT NO. 60812 EXPIRES: 11 /2012

    Distribution

    USA Nationwide Distribution including the states GA, OH, GA, NC and ME.

    Quantity

    80 trays