BEUDAMED
    FDA Enforcement Class I Terminated

    Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.

    Recall: Z-1668-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1668-2013
    Event ID
    65430
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic MiniMed
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2013
    Initiation Date
    June 7, 2013
    Classification Date
    July 9, 2013
    Termination Date
    June 10, 2015
    Address
    18000 Devonshire St, N/A, Northridge, CA, 91325-1219, United States

    Description

    Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.

    Reason

    Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin.

    Code Info

    This field correction involves models: MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm Infusion sets.

    Distribution

    Worldwide distribution: US (nationwide) distribution: Algeria, Argentina, Australia, Bahamas, Bahrain, Bermuda, Boliva, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Southern Territories, Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Netherlands, Norway, New Zealand, Oman, Panama, Paraguay, Peru, Poland, Province of China, Taiwan, Qatar, Republic of Korea, Romania, Russia Federation, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, Uruguay, and¿Venezuela.

    Quantity

    11,000,000 units