BEUDAMED
    FDA Recall Terminated

    Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100 Intended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic billary procedures for catheter introduction and exchanges.

    Recall: Z-0558-2009 · Initiated August 8, 2008

    Recall

    Recall Number
    Z-0558-2009
    Event Number
    49510
    Firm
    Sterilmed Inc
    FEI Number
    3001237663
    Product Code
    NML
    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

    Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100 Intended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic billary procedures for catheter introduction and exchanges.

    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

    2