BEUDAMED
    FDA Recall Terminated

    Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 40 ml Pumps Model 8637-40 The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.

    Recall: Z-2182-2008 · Initiated May 1, 2008

    Recall

    Recall Number
    Z-2182-2008
    Event Number
    48635
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 1, 2008
    Posted
    September 3, 2008
    Terminated
    December 11, 2011
    Address
    800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250

    Description

    Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 40 ml Pumps Model 8637-40 The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.

    Reason

    SynchroMed II pumps (non-implanted) may have been manufactured without propellant.

    Action

    Consignees were contacted by "Medtronic Urgent: Medical Device Recall" letters dated May 2008. The SynchoMed II pumps may have been manufactured without propellant. This device is limited to non-implanted SynchoMedl II pumps. Physcians should not impant these potentially affected pumps. The notifcation provides information on how to identify Pumps Without Propellant, Patient Management Recommendations and Additional Resources. A separate letter was issued to Inventory/Risk Mangers. The letter described the product and problem and included a section on the Product Recall, Returning Product and Accounting for Lost Inventory Product. Contact Medtronic at 1-800-707-0933.

    Distribution

    AK, AL, AR, AZ, CA, DO, CT, DC, DE, FL, GA, HI, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, HY, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, DS, TN, TX, UT, VA, VT, WA, WI, WV, WY, Australia, Canada ,Austria, Belgium, Cyprus, Russian Federation, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Ireland, Italy, Kuwait, Luxembourg, Netherlands, Norway, Poland, Portugal, Reunion, San Marino, Slovenia, South Africa, Spain, Sweden Switzerland, Turkey, United Arab Emirates, United Kingdom, Vatican City, Saudi Arabia, Hong Kong, Latin America, Brazil, Puerto Rico, and Dominican Republic.

    Quantity

    6047