BEUDAMED
    FDA Recall Terminated

    Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.

    Recall: Z-1497-2014 · Initiated March 11, 2014

    Recall

    Recall Number
    Z-1497-2014
    Event Number
    67895
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GAQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 11, 2014
    Posted
    April 24, 2014
    Terminated
    December 17, 2015
    Address
    2917 Weck Dr., Research Triangle Park, NC, 27709

    Description

    Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.

    Reason

    The products are being recalled because they did not meet minimum diameter requirements.

    Action

    Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected constomers. The letter identified the affected product, problem and actions to be taken. Customers were instructed if they have affected stock immediately discontinue use, quarantine, and return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgement Form and Fax it to 1-508-964-6078, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-508-964-6042.

    Distribution

    Worldwide Distribution - CA, CO, FL, IN, KY, MA, NM, PA, Canada, Ireland and Germany.

    Quantity

    3,816 ea