BEUDAMED
    FDA Enforcement Class I Ongoing

    3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370

    Recall: Z-2483-2025 · Reported September 24, 2025

    Enforcement

    Recall Number
    Z-2483-2025
    Event ID
    96841
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    3M Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2025
    Initiation Date
    April 10, 2025
    Classification Date
    September 18, 2025
    Address
    2510 Conway Ave E, 3m Center, Building 275-5w-06, Saint Paul, MN, 55144-0001, United States

    Description

    3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370

    Reason

    Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.

    Code Info

    All lots with a manufacturing date after March 2022.

    Distribution

    Worldwide distribution. US nationwide including Puerto Rico, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, Canary Islands, China, Costa Rica, Croatia, Czechia, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Luxembourg, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, UK, and Vietnam.

    Quantity

    530,470 units