BEUDAMED
    FDA Enforcement Class II Terminated

    Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.

    Recall: Z-0681-2019 · Reported January 2, 2019

    Enforcement

    Recall Number
    Z-0681-2019
    Event ID
    81640
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Action Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2019
    Initiation Date
    November 27, 2018
    Classification Date
    December 22, 2018
    Termination Date
    February 8, 2019
    Address
    25 Heywood Rd, Arden, NC, 28704-9302, United States

    Description

    Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.

    Reason

    Potential compromise of product sterility due to breach of sterile barrier.

    Code Info

    Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111

    Distribution

    Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.

    Quantity

    13 cases (2,600 sponges)