BEUDAMED
    FDA Enforcement Class II Terminated

    Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

    Recall: Z-0603-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0603-2013
    Event ID
    61734
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medrad Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2012
    Initiation Date
    April 18, 2012
    Classification Date
    December 20, 2012
    Termination Date
    August 17, 2015
    Address
    1 Medrad Dr, Indianola, PA, 15051-9759, United States

    Description

    Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.

    Reason

    Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in flow rate accuracy performance issues.

    Code Info

    Catalog number - Secondary Spike Set: 3015160. See firm's website - www.medrad.com for specific serial and lot numbers.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: Australia, Bermuda, Brazil, Canada, China, Chile, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Guam, Hong Kong, India, Israel, Italy, Japan, Korea, Lebanon, Mexico, Malaysia, Netherland, Poland, Portugal, Puerto Rico, Sweden, Singapore, Taiwan, Thailand, and Venezula.

    Quantity

    1,229 Pumps total