BEUDAMED
    FDA Recall Terminated

    Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5 and 530/590 series GI Endoscopes w/o Water Jet. The QFC1729 is used to process 250/450 Group 5 and 530/590 series Endoscopes w/ Water Jet.

    Recall: Z-0967-2007 · Initiated February 23, 2007

    Recall

    Recall Number
    Z-0967-2007
    Event Number
    37493
    Firm
    Steris Corp
    FEI Number
    1527821
    Product Code
    MED
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 23, 2007
    Posted
    June 21, 2007
    Terminated
    March 1, 2012
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5 and 530/590 series GI Endoscopes w/o Water Jet. The QFC1729 is used to process 250/450 Group 5 and 530/590 series Endoscopes w/ Water Jet.

    Reason

    The center insert of the adaptor #6 restrictor could become loose and/or come out of the housing and may affect the sterilization process of the attached endoscope

    Action

    On February 22, 2007, customers were contacted by phone and were notified by recall letter dated February 23, 2007. The recall notifications indicate that Steris Account managers will visit each consignee and replace affect product.

    Distribution

    Worldwide-The product was distributed to USA domestic consignees located in MT, CA, NJ, IA, MA, WY, SC, MO, SC, TN, ID, MT, CO, PA, NV, and TX, and to foreign consignees located in Great Britian and Qatar.

    Quantity

    146