BEUDAMED
    FDA Recall Terminated

    Custom Breast Biopsy Tray, Catalog # B 9-16261, 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-0796-2013 · Initiated November 26, 2012

    Recall

    Recall Number
    Z-0796-2013
    Event Number
    64084
    Firm
    Custom Healthcare Systems, Inc.
    FEI Number
    1121091
    Product Code
    FCH
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    November 26, 2012
    Posted
    February 7, 2013
    Terminated
    February 8, 2013
    Address
    4205 Eubank Rd, Richmond, VA, 23231-4328

    Description

    Custom Breast Biopsy Tray, Catalog # B 9-16261, 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.

    Action

    Custom Healthcare Systems, Inc. sent an Urgent Recall Letter dated November 19, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, quarantine affected product and return affected product to Stericycle using the label provided with the letter. Customer were also requested to complete and return the enclosed recall response form. For questions contact Hospira Customer Care at 1-877-946-7747.

    Distribution

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

    Quantity

    80 trays