BEUDAMED
    FDA Recall Terminated

    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

    Recall: Z-2190-2015 · Initiated June 15, 2015

    Recall

    Recall Number
    Z-2190-2015
    Event Number
    71525
    Firm
    Mermaid Medical A/S Frydensbergvej 25 Stenl?se Denmark
    FEI Number
    3007146453
    Product Code
    DWO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 15, 2015
    Posted
    July 22, 2015
    Terminated
    December 7, 2015

    Description

    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

    Reason

    Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula.

    Action

    The firm, Mermaid Medical, notified both customers directly via email with written letters dated June 12 and June 15, 2015 followed up by sales and customer service for product return to MMI. The customers were instructed to "Please coordinate the return of the mentioned products with corresponding lot numbers with our Mermaid Medical's Customer Care the recalled product: either by phone at 1{720}420-9999 or by email: [email protected]". If you have any questions please do not hesitate to contact Vice President QA & Regulatory Affairs toll free at (855) 427-6799 or (720) 420-9999 or email: [email protected].

    Distribution

    US Distribution to FL including PR.

    Quantity

    320