BEUDAMED
    FDA Recall Open, Classified

    SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 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-0553-2026 · Initiated September 26, 2025

    Recall

    Recall Number
    Z-0553-2026
    Event Number
    97592
    Firm
    ASP Global, LLC. dba Anatomy Supply Partners, LLC.
    FEI Number
    3004824601
    Product Code
    JKA
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    September 26, 2025
    Posted
    November 19, 2025
    Address
    7800 Third Flag Pkwy, Austell, GA, 30168-7657

    Description

    SAFE-T-FILL Micro Capillary Blood Collection, 200 L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 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.

    Action

    On 09/26-29/2025, ASP Global emailed an URGENT MEDICAL DEVICE RECALL Letter to customers. ASP Global, LLC, is voluntarily recalling all RAM Scientific SAFE-T-FILL products within remaining expiry. ASP Global was made aware that our contract manufacturer for the RAM Scientific SAFE-T-FILL products was issued an FDA Warning Letter citing significant violations of the Quality System requirements, including inadequate production and process controls, as well as design controls. Customers are instructed to: a) Discontinue use of the recalled products immediately. b) Quarantine any remaining inventory to prevent further use. c) If critical or abnormal test results were obtained using the affected SAFE-T-FILL products, ensure they are verified through repeat or confirmatory testing in accordance with institutional protocols (e.g., venous confirmation of abnormal pediatric screening results). d) Dispose remaining inventory in accordance with your local facility guidelines or notify ASP Global at [email protected] for return authorization and disposal. e) Complete and return the Recall Response Form to confirm receipt and actions to [email protected]. For questions or assistance - contact [email protected] (855)-867-2190| Mon Fri, 9:00 AM 5:00 PM ET

    Distribution

    Distribution US nationwide and Canada.

    Quantity

    2100