BEUDAMED
    FDA Recall Terminated

    CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console.

    Recall: Z-0079-2007 · Initiated May 5, 2006

    Recall

    Recall Number
    Z-0079-2007
    Event Number
    35745
    Firm
    ATS Medical, Inc.
    FEI Number
    3008592544
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2006
    Posted
    October 28, 2006
    Terminated
    November 2, 2006
    Address
    3905 Annapolis Ln N, Ste 105, Minneapolis, MN, 55447-5473

    Description

    CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console.

    Reason

    Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiratation date while the correct date is one (1) year.

    Action

    Consignee''s were notified by ATS Medical Representatives via visits. Product was either relabeled with correct expiration date or retrieved by ATS Medical representatives.

    Distribution

    Nationwide-ATS Medical distirubted devices to hospitals located in the following states IN, KS, MO, TX. There may be other US distributors of this product.

    Quantity

    219 units