BEUDAMED
    FDA Recall Open, Classified

    Medicina Oral Tip Syringe 1ml Code: OT01

    Recall: Z-0110-2023 · Initiated July 4, 2022

    Recall

    Recall Number
    Z-0110-2023
    Event Number
    90849
    Firm
    Medicina Uk Ltd
    FEI Number
    3008432385
    Product Code
    KYW
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 4, 2022
    Posted
    October 20, 2022
    Address
    Rivington View Business Park Bolton United Kingdom Unit 2

    Description

    Medicina Oral Tip Syringe 1ml Code: OT01

    Reason

    Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

    Action

    Medicina Ltd issued Field Safety Corrective Action notice to the US Distributor 07/04/2022 via email. The US Distributor is conducting recall to the user level letter issued the week of July 25th via United States Postal Service. . Letter states reason for recall, health risk and action to take: Action to be taken - Please carefully read this Field Safety Notice and return the Acknowledgement Form - Please do not use any of the batches of product listed on this notice - If you have product to return, please complete the information on the Acknowledgement Form and our team will arrange the return for you - Please distribute throughout your organisations and to relevant personnel - If you have any questions or queries in relation to this notice, please contact us using the information below Contact information regarding FSN Shaista Patel QA/RA Administrator Unit 2, Rivington View Business Park, Station Road, Blackrod, Bolton BL6 5BN Email: [email protected] Tel: 01204 695050

    Distribution

    Nationwide

    Quantity

    29 boxes (2900 syringes)