BEUDAMED
    FDA Recall Terminated

    Ultrasound probe cover, sterile. Catalog No. 910811.

    Recall: Z-1571-05 · Initiated June 7, 2005

    Recall

    Recall Number
    Z-1571-05
    Event Number
    33313
    Firm
    North Coast Medi-Tek Inc
    FEI Number
    1526414
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2005
    Posted
    September 21, 2005
    Terminated
    December 17, 2007
    Address
    8603 East Ave, Mentor, OH, 44060-4366

    Description

    Ultrasound probe cover, sterile. Catalog No. 910811.

    Reason

    Customer observed unsealed packages.

    Action

    The recalling firm called their customer and requested the customer to return un-sealed packages.

    Distribution

    The product was distributed to one consignee: Cone Instruments, 5210 Naiman Parkway, Solon, OH 44139.

    Quantity

    30 cases containing 10 units per case.