BEUDAMED
    FDA Recall Terminated

    (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140

    Recall: Z-0846-2020 · Initiated December 17, 2019

    Recall

    Recall Number
    Z-0846-2020
    Event Number
    84661
    Firm
    Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands
    FEI Number
    3012037425
    Product Code
    GAA
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    December 17, 2019
    Terminated
    December 9, 2020

    Description

    (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140

    Reason

    Microscopic tears of the sterile pouch may compromise sterility

    Action

    VitreQ issued Urgent Medical Device recall dated 12/16/19 letter states reason for recall, health risk and action to take: 1.Immediately examine your inventory and quarantine product from all lots subject to recall. If you have further distributed this product, please identify your customers and notify them at once of this product recall. Consider all potential users of this product in your user supply chain. You may provide a copy of this recall notification letter; 2.Complete the Attachment 1: Response Form enclosed IMMEDIATELY, as evidence of the product being returned, and we will credit your account or complete the response form even if you do not have product to return.3.Return the Attachment 1: Response Form to BVI by one of these methods: Fax 866-906-4304 or email a copy to [email protected]. If you have any specific product replacement questions you may contact Customer Service Team at: [email protected] or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).

    Distribution

    Nationwide