BEUDAMED
    FDA Enforcement Class II Terminated

    Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.

    Recall: Z-0444-2019 · Reported November 21, 2018

    Enforcement

    Recall Number
    Z-0444-2019
    Event ID
    81003
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Espiner Medical Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 21, 2018
    Initiation Date
    June 20, 2018
    Classification Date
    November 9, 2018
    Termination Date
    December 9, 2019
    Address
    Yeo Bank, 3, Kenn Road, Clevedon, N/A, United Kingdom

    Description

    Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and removed from the body cavity.

    Reason

    Label was incorrect. The label states that the volume of the retrieval bag was 1200ml, but it should state 1000ml

    Code Info

    Lot Numbers/Exp Date: A2578 2020/01; A3162 2020/10; 1603 2022/0l; 2184 2022/08

    Distribution

    US Nationwide in the states of CA, IL, MT, NC, NJ,

    Quantity

    230 units