BEUDAMED
    FDA Recall Open, Classified

    Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.

    Recall: Z-0829-2022 · Initiated February 21, 2022

    Recall

    Recall Number
    Z-0829-2022
    Event Number
    89598
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    FSA
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 21, 2022
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.

    Reason

    An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.

    Action

    The recalling firm issued letters to U.S. consignees on 2/21/2022 via UPS ground. The letter provided a description of the problem with the background which included photographs and views of the issue. The potential risk was explained and actions to be taken by the customer were provided, which included to identify whether they have an impacted product and to return the enclosed response form within two weeks. Upon receipt of the response form, Hillrom will contact the consignee to arrange to inspect the Twinbar and if the short bolts have been used, the Twinbar will be corrected. The consignee was instructed not to use the Twinbar together with a Liko Scale until an inspection has been completed. Distributors were instructed to share the Medical Device Correction with their end users and complete the attached response form for return within two weeks. Hillrom will provide replacements for distributors to facilitate exchange among end users. A 3rd party recall service will be issuing notifications to the OUS consignees.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, ND, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. There was government distribution but no military distribution. The countries of Austria, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, Ireland, Japan, Jordan, Latvia, Netherlands, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Kingdom, and Uruguay.

    Quantity

    1,399 twinbars