BEUDAMED
    FDA Recall Terminated

    Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F

    Recall: Z-1229-2020 · Initiated October 18, 2019

    Recall

    Recall Number
    Z-1229-2020
    Event Number
    84742
    Firm
    Taewoong Medical Co., Ltd. 14 Gojeong-ro, Wolgot-Myeon, Gimpo-Si, Gyeonggi-Do Korea (the Republic of)
    FEI Number
    3003902943
    Product Code
    ESW
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 18, 2019
    Terminated
    October 15, 2021

    Description

    Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F

    Reason

    Misprinted IFUs shipped with esophageal stents

    Action

    On 10/18/19, an Esophageal Stent Device Return notices were emailed to the U.S. distributor who was asked to stop releasing products. The distributor was further asked to do the following for products already distributed: please send customers a notification to stop using the product immediately and to return affected product. Then the distributor was asked to return all affected products in their possession including returned products to the manufacturer. e-mail contact: [email protected]

    Distribution

    U.S.: IN

    Quantity

    178