BEUDAMED
    FDA Enforcement Class II Ongoing

    ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device UPN: (1)Twin Pack Box 1 M00519210; (2)Twin Pack Box 10 M00519211; (3)Single Pack Box 10 M00519231

    Recall: Z-0225-2023 · Reported November 16, 2022

    Enforcement

    Recall Number
    Z-0225-2023
    Event ID
    90986
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 16, 2022
    Initiation Date
    October 10, 2022
    Classification Date
    November 10, 2022
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device UPN: (1)Twin Pack Box 1 M00519210; (2)Twin Pack Box 10 M00519211; (3)Single Pack Box 10 M00519231

    Reason

    ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention

    Code Info

    GTIN Number : (1)08714729974581 (2)08714729974598 (3)08714729993865 All batches

    Distribution

    Worldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria Argentina Argentina Australia Austria Bahrain Belgium Brazil Canada Chile Colombia Costa Rica Cyprus Czech Republic Denmark Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong Hungary Iceland Iraq Ireland Israel Italy Jordan Kuwait Latvia Lebanon Lithuania Luxembourg Mexico Netherlands New Zealand Norway Oman Palestine Panama Per¿ Poland Portugal Romania Russian Fed. Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Unit.Arab Emir. Zimbabwe

    Quantity

    402,968 Total