BEUDAMED
    FDA Enforcement Class II Terminated

    Container fill and transfer sets, 250 mL and 500 mL, . .

    Recall: Z-2264-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2264-2016
    Event ID
    74043
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Metrix Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    June 23, 2016
    Classification Date
    July 22, 2016
    Termination Date
    April 11, 2023
    Address
    4400 Chavenelle Rd, N/A, Dubuque, IA, 52002-2655, United States

    Description

    Container fill and transfer sets, 250 mL and 500 mL, . .

    Reason

    An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

    Code Info

    All lots are being recalled. Lot code consists of the five digit product code followed by a dash followed by a unique five character numeric or alphanumeric sequence. Affected product codes for this product: 66505 and 66510

    Distribution

    Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom

    Quantity

    1,350 cases