BEUDAMED
    FDA Recall Terminated

    DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03

    Recall: Z-0198-2020 · Initiated July 3, 2019

    Recall

    Recall Number
    Z-0198-2020
    Event Number
    83386
    Firm
    Valeritas, Incorporated
    FEI Number
    3003154078
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 3, 2019
    Terminated
    June 24, 2020
    Address
    293 Boston Post Rd W, Ste 330, Marlborough, MA, 01752-4615

    Description

    DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03

    Reason

    There is a potential for "No Needle Demo Units" to contain a needle.

    Action

    On July 3, 2019, Valeritas issued notices to customers via first class U.S. postal service. The removal strategy is to notify active HCP office accounts from the manufacturing start date of effected product (January 2018) who may have No Needle Demo units in their possession. The removal letter instructs HCP offices to dispose of any No Needle Demo product on hand and acknowledgement by signing and returning the removal letter as instructed.

    Distribution

    Nationwide within U.S.

    Quantity

    852 devices