BEUDAMED
    FDA Enforcement Class II Terminated

    Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Green Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture, USP, Deknatel; Bard FIXT Braided Polyester, Green PTFE Rx Only, Teleflex Research Triangle Park, NC USA, Assembled in Mexico. Indicated for use in soft tissue approximation.

    Recall: Z-1556-2014 · Reported May 14, 2014

    Enforcement

    Recall Number
    Z-1556-2014
    Event ID
    67711
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 14, 2014
    Initiation Date
    March 11, 2014
    Classification Date
    May 6, 2014
    Termination Date
    August 14, 2017
    Address
    4024 Stirrup Creek Dr, N/A, Durham, NC, 27703-9000, United States

    Description

    Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Green Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture, USP, Deknatel; Bard FIXT Braided Polyester, Green PTFE Rx Only, Teleflex Research Triangle Park, NC USA, Assembled in Mexico. Indicated for use in soft tissue approximation.

    Reason

    Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

    Code Info

    Product Code 0100019-507 -Lot 02F1301128, Product Code 6-511 - Lot 02M0800561, Product Code 6-559 - Lot 02A0800005, Product Code 69-403 - Lot 02H0802530, Product Code 7-5008M4 - Lot 02C0900466, Product Code 7-518 - Lot 02E1302561, Product Code 7-565 - Lot 02B1100185, Product Code 7-655A - Lot 02C0901963, Product Code 7-655A - Lot 02M0800836, Product Code 7-740 - Lot 02L1000536, Product Code 833-114 - Lot 02A1202112, 02C0902841, 02C0903374, 02D1202794, 02F0902697, 02K1100404, 02L1202369, 02M0802509, Product Code E13-6351 - Lot 02F0902446, Product Code E13-6354 - Lot 02F0902439, Product Code E13-6399 - Lot 02F0902436, Product Code E6-545 Lot 02F0902443, Product Code E7-4578 Lot 02D0901672, Product Code RN6-5106M5 - Lot 02F1003837, Product Code RN7-536M5 - Lot 02A0801205, Product Code TEV100 - Lot 02G1101500, Product Code V-2599 - Lot 02F0802055, 02F0802055, Product Code X-5424 - Lot 02B0900765, Product Code X6-692W - Lot 02C0803135, Product Code X7-655M6A - Lot 02A0900806, 02A0902742, 02C0900446, 02H1003233, Product Code XF7-7011 - Lot 02A0901594

    Distribution

    Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

    Quantity

    32,271 ea.