BEUDAMED
    FDA Recall Terminated

    Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031 BED73000 BED73010 BED74000 BED74010 NURBPP-30A NURBPP-30WC POS8283 RFT1000-1210 RFT1000-1250 RFT1000-1810 and RFT1000-1820 A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.

    Recall: Z-0547-2009 · Initiated August 8, 2008

    Recall

    Recall Number
    Z-0547-2009
    Event Number
    49510
    Firm
    Sterilmed Inc
    FEI Number
    3001237663
    Product Code
    KMI
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 8, 2008
    Posted
    January 13, 2009
    Terminated
    April 26, 2011
    Address
    11400 73rd Ave N, Ste 100, Osseo, MN, 55369-5562

    Description

    Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031 BED73000 BED73010 BED74000 BED74010 NURBPP-30A NURBPP-30WC POS8283 RFT1000-1210 RFT1000-1250 RFT1000-1810 and RFT1000-1820 A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.

    Reason

    SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable

    Action

    Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.

    Distribution

    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA

    Quantity

    352