BEUDAMED
    FDA Enforcement Class II Terminated

    Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.

    Recall: Z-1535-2014 · Reported May 7, 2014

    Enforcement

    Recall Number
    Z-1535-2014
    Event ID
    67973
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 7, 2014
    Initiation Date
    March 11, 2014
    Classification Date
    May 1, 2014
    Termination Date
    March 29, 2016
    Address
    2917 Weck Dr., Research Triangle Park, NC, 27709, United States

    Description

    Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.

    Reason

    The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.

    Code Info

    Product Code: 200101-01, Lot # 02F0801290 and Product Code: BP1000V2L, Lot numbers: 02C1003535 & 02F1000711.

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.

    Quantity

    7,380 ea (total)