BEUDAMED
    FDA Recall Terminated

    Wallach LL100 Cryosurgical Freezer No Connector CO2 System Model: 900047.

    Recall: Z-0099-2010 · Initiated September 29, 2009

    Recall

    Recall Number
    Z-0099-2010
    Event Number
    53436
    Firm
    Cooper Surgical, Inc.
    FEI Number
    1216677
    Product Code
    GEH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 29, 2009
    Posted
    October 29, 2009
    Terminated
    April 17, 2012
    Address
    95 Corporate Dr, Trumbull, CT, 06611

    Description

    Wallach LL100 Cryosurgical Freezer No Connector CO2 System Model: 900047.

    Reason

    CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.

    Action

    Cooper Surgical notified customers by letter titled "Notice of Recall - Urgent" dated September 29, 2009 advising them of the problem and requesting return of the device. International accounts were notified by letter Beginning October 1, 2009. For further information, contact Cooper Surgical by fax at 1-203-799-2002 or phone at 1-203-799-2000.

    Distribution

    Worldwide Distribution -- United States, Canada, Australia, Belgium, England, France, Germany, Greece, Hungary, Iceland, Italy, Ireland, Latvia, Lithuania, Netherlands, Portugal, Spain, Solvenia, Sweden, Hong Kong, Republic of China, Taiwan, Angola, Cameroon, Congo, Croatia, Egypt, Ghana, Guam, Guineae Bissau, Indonesia, Kenya, Kuwait, Lebanon, Madagascar, Mali, Mauritania, Mozambique, New Zealand, Niger, Pakistan,Qatar, Russia, Sao Tome, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, St Vincents & Grenadines, Oman, Thailand, Turkey, UAE and Zimbabwe.