BEUDAMED
    FDA Recall Open, Classified

    AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222

    Recall: Z-0819-2025 · Initiated November 26, 2024

    Recall

    Recall Number
    Z-0819-2025
    Event Number
    95881
    Firm
    Applied Medical Technology Inc
    FEI Number
    1526012
    Product Code
    PIF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 26, 2024
    Posted
    January 7, 2025
    Address
    8006 Katherine Blvd, Brecksville, OH, 44141-4202

    Description

    AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222

    Reason

    The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.

    Action

    An "URGENT: MEDICAL DEVICE RECALL" notification letter dated 11/26/24 was sent to customers. ACTIONS TO BE TAKEN: CUSTOMER OR USER: Applied Medical Technology, Inc. requests that customers IMMEDIATELY TAKE THE FOLLOWING ACTIONS: " Examine your inventory and isolate/quarantine pending return of the product subject to this recall. " Do not use any device subject to this recall. " Complete and return to Applied Medical Technology, Inc. the enclosed RECALL NOTIFICATION ACKNOWLEDGMENT via fax or send by mail. " Please contact Applied Medical Technology, Inc. either by phone at 440-717-4000, or via email at [email protected], to make arrangements for the return of any devices related to this recall. Include the product, all of its components, and any available packaging and labeling associated with the device. An RMA number will only be issued for pouches with lot number 240424-628. Please contact us with any questions or concerns: Public Recall Contact: Customer Service Address: Applied Medical Technology, Inc. Attn: Customer Service 8006 Katherine Blvd Brecksville, OH 44141 USA Telephone: 440-717-4000 Fax: 440-717-4200 Email: [email protected] General hours of operation are 8:30am to 5:00pm. All times in Eastern Standard Time Zone.

    Distribution

    US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA

    Quantity

    100