BEUDAMED
    FDA Recall Terminated

    McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178CK30

    Recall: Z-1080-2019 · Initiated February 27, 2019

    Recall

    Recall Number
    Z-1080-2019
    Event Number
    82312
    Firm
    Cypress Medical Products LLC
    FEI Number
    1451040
    Product Code
    KHE
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    February 27, 2019
    Terminated
    May 21, 2021
    Address
    9954 Mayland Dr, Richmond, VA, 23233-1464

    Description

    McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178CK30

    Reason

    Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.

    Action

    On February 27, 2019, Cypress Medical Products, LLC, notified their single customer and distributor, McKesson Medical Surgical via Urgent Voluntary Medical Device Recall letter. McKesson then notified their affected distribution centers. The letter instructed the customer to check the stock for affected product. If the customer has affected product, the customer is to cease distribution and quarantine immediately. Recipients were also asked to complete the reply form that was included with the letter, even if you do not have any affected product in your possession at the distribution centers.

    Distribution

    Shipped to distribution centers located in AL, AR, AZ, CA, CO, FL, GA, HI, IL, KY, LA, MA, MN, MO, MS, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA, and WI.

    Quantity

    1165 cases