BEUDAMED
    FDA Recall Terminated

    Ultrakleen KSponge II Spears Catalog #: K20-5012

    Recall: Z-0487-03 · Initiated January 8, 2003

    Recall

    Recall Number
    Z-0487-03
    Event Number
    25224
    Firm
    Ultracell Medical Technologies
    FEI Number
    1000120594
    Product Code
    HOZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 8, 2003
    Posted
    January 30, 2003
    Terminated
    May 1, 2012
    Address
    183 Providence, North Stonington, CT, 06359

    Description

    Ultrakleen KSponge II Spears Catalog #: K20-5012

    Reason

    Sterility of the device is compromised

    Action

    Ultracell Medical Technologies initiated the recall by fax or mail on 1/8/03. The firm requested return of product . Distributors were requestd to recall to their accounts.

    Distribution

    Nationwide

    Quantity

    4,047 units