BEUDAMED
    FDA Enforcement Class II Completed

    ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

    Recall: Z-1768-2022 · Reported September 28, 2022

    Enforcement

    Recall Number
    Z-1768-2022
    Event ID
    90743
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    GELITA MEDICAL GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 28, 2022
    Initiation Date
    July 27, 2022
    Classification Date
    September 19, 2022
    Address
    Uferstr. 7, N/A, Eberbach, N/A, N/A, Germany

    Description

    ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

    Reason

    In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.

    Code Info

    UDI/DI 00860003109915, Batch Numbers: T02371/1, expiration date 10.02.2026; T02371/2, expiration date 10.02.2026; T02395/1, expiration date 07.05.2026; T02394/2, expiration date 07.05.2026

    Distribution

    US Nationwide distribution in the state of Alabama.

    Quantity

    3596 boxes of 50 devices