BEUDAMED
    FDA Recall Terminated

    Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 mL.

    Recall: Z-2260-2016 · Initiated June 23, 2016

    Recall

    Recall Number
    Z-2260-2016
    Event Number
    74043
    Firm
    The Metrix Company
    FEI Number
    1000117446
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 23, 2016
    Terminated
    April 11, 2023
    Address
    4400 Chavenelle Rd, Dubuque, IA, 52002-2655

    Description

    Container fill and transfer sets, 250 mL, 500 mL, 1000 mL, 2000 mL, 3000 mL, or 4000 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.

    Action

    On 6/23/2016, the recalling firm sent written recall notices to their distributors and end users notifying them of the recall. Customers and consignees were instructed to not use the devices, locate and quarantine all affected devices, and to complete the response form.

    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

    137,598 cases