BEUDAMED
    FDA Recall Terminated

    Maximum Pelvic Trainer (MPT)

    Recall: Z-2087-2019 · Initiated July 12, 2019

    Recall

    Recall Number
    Z-2087-2019
    Event Number
    83328
    Firm
    Ralston Group
    FEI Number
    3002688031
    Product Code
    HIR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 12, 2019
    Terminated
    April 15, 2022
    Address
    656 Lake Lanier Rd, Selma, AL, 36701-3820

    Description

    Maximum Pelvic Trainer (MPT)

    Reason

    The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device.

    Action

    Ralston Group notified customers on about 07/12/2019 via "IMPORTANT VOLUNTARY: MEDICAL DEVICE RECALL" email. Customers were advised that the device was incorrectly registered with the FDA and is therefore considered adulterated and misbranded if left on the market. Processes and documentation regarding the manufacture of this device were not adequately maintained. Also, clinical trials and claims concerning the effectiveness of the MPT were not evaluated by the FDA. Instructions included to immediately examine inventory for affected product, discontinue use/distribution, and quarantine al affected product. Customers were requested to complete the provided MEDICAL DEVICE RECALL RETURN RESPONSE to confirm receipt and understanding, and arrange for return of all affected product by contacting customer service at [email protected] or call 1-800-867-3726, Monday -Friday 8 AM 5 PM Central Time. Also customers were instructed to notify customers if the product was further distributed.

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and PR.

    Quantity

    534 units