BEUDAMED
    FDA Recall Terminated

    Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Remington Medical, Inc., Alpharetta, GA 30005.

    Recall: Z-0058-2008 · Initiated July 23, 2007

    Recall

    Recall Number
    Z-0058-2008
    Event Number
    44938
    Firm
    Remington Medical Inc.
    FEI Number
    1000132370
    Product Code
    EXF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 23, 2007
    Posted
    October 23, 2007
    Terminated
    April 6, 2009
    Address
    6830 Meadowridge Ct., Alpharetta, GA, 30005

    Description

    Remington Medical, Inc, (RMI) -- Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Remington Medical, Inc., Alpharetta, GA 30005.

    Reason

    Sterility, inadequate -- Pathway may not be sterile as labeled.

    Action

    Consignees were notified by Urgent Recall Letter (dated 07/23/07) via fax from 07/24/2007 through 07/27/2007. They were instructed to quarantine all affected product in inventory. If product was distributed they were instructed to identify their customers and notify them of the recall via copy of the notification letter.

    Distribution

    Nationwide Distribution -- including states of AL, AR, AZ, CA, CO, CT, GA, HI, IL, IN, KS, KY, MD, MI, MT, NB, NC, OH, NY, PA, RI, TN, WA, WV, and WY.

    Quantity

    45,000 units