BEUDAMED
    FDA Recall Terminated

    GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, GYN Disposables,Inc. 2671 Appling Road, Memphis, TN 38133, ph 901.377.2200, fx 901.377.2207 Intended for intrauterine device (IUD) insertion.

    Recall: Z-3025-2011 · Initiated July 29, 2011

    Recall

    Recall Number
    Z-3025-2011
    Event Number
    59661
    Firm
    GYN Disposables Inc
    FEI Number
    1000111025
    Product Code
    HDC
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 29, 2011
    Posted
    August 15, 2011
    Terminated
    October 29, 2012
    Address
    3150 Stage Post Dr, Ste 103, Memphis, TN, 38133-4050

    Description

    GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, GYN Disposables,Inc. 2671 Appling Road, Memphis, TN 38133, ph 901.377.2200, fx 901.377.2207 Intended for intrauterine device (IUD) insertion.

    Reason

    Lack of sterility assurance.

    Action

    GYN Disposables Inc. sent out an "Urgent: Medical Device Recall" letter dated July 29, 2011 to all affected customers The letter includes: product affected, description of problem and asks customers quarantine all affected product. They can contact GYN Disposables to have the product picked up and to receive credit. A Response Form is also included. For questions on this recall call (888) 372-2203, extension 101.

    Distribution

    Nationwide Distribution.

    Quantity

    3987 units