BEUDAMED
    FDA Enforcement Class II Ongoing

    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    Recall: Z-0548-2026 · Reported November 26, 2025

    Enforcement

    Recall Number
    Z-0548-2026
    Event ID
    97592
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ASP Global, LLC. dba Anatomy Supply Partners, LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2025
    Initiation Date
    September 26, 2025
    Classification Date
    November 19, 2025
    Address
    7800 Third Flag Pkwy, Austell, GA, 30168-7657, United States

    Description

    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.

    Reason

    Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

    Code Info

    Model Number: 07 7151 GTIN (Inner Pack): 30643351000179 UDI-DI: 10643351000175 All Lots produced from 01AUG2023 to 28FEB2025: 24I4329, 24J4346, 25B4105

    Distribution

    Distribution US nationwide and Canada.

    Quantity

    6600