BEUDAMED
    FDA Enforcement Class II Terminated

    Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.

    Recall: Z-0861-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0861-2014
    Event ID
    65179
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Codman & Shurtleff, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    May 16, 2013
    Classification Date
    January 28, 2014
    Termination Date
    June 2, 2015
    Address
    325 Paramount Drive, Raynham, MA, 02767, United States

    Description

    Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.

    Reason

    Codman Certas Programmable Valves used for hydrocephalus may not operate properly

    Code Info

    Lot Codes: CNMCDP CNMDM2 CNMDNG CNFCVJ CNHB96 CNHC8L CNHCZM CNHCZT CNJBWW CNJBWY CNJCFP CNJCG9 CNKB0R CNKBTR CNKCL0 CNKCL2 CNLBR2 CNLBZD CNMCDV CNMDM3 CNNCWC CNPB1W CNPBRJ CNPCLP CPBB39 CPBBGN CPBC98 CPBCKR CPBCKT CPCBG7 CPCCBG CPDBYH CPDC09 CPDCC4 CNBB13 CNCB6L CNDB8B CNDBVZ CNDCM9 CNHC8J CNHCKG CNJC39 CNJC4H CNJC4J CNJCB0 CNDCM8 CNKB42 CNFCVH CNHCZH CNJB98 CNLCW4 CNMBFK CNMCDW CNMDNH CNNCWH CNNDH2 CNNDH3 CNPB1V CPBB3H CPBCR0 CPCBG6 CPCCBD CPCCBF CPDBYG CPDCC6 CMMB1L CMBC2W CMDBHB CMDDJP CMDDJR CMKB22 CMLCKR CMMCR5 CMNBFD CMNCVP CMNCYM CMPB95 CMPBMD CNBBCZ CNCB4R CNCB61 CNMCDR CPCCMW

    Distribution

    Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.

    Quantity

    1481 units