BEUDAMED
    FDA Recall Open, Classified

    JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900

    Recall: Z-2637-2025 · Initiated July 1, 2025

    Recall

    Recall Number
    Z-2637-2025
    Event Number
    97308
    Firm
    North American Rescue LLC.
    FEI Number
    3005034064
    Product Code
    DXC
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 1, 2025
    Posted
    September 26, 2025
    Address
    35 Tedwall Ct, Greer, SC, 29650-4791

    Description

    JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900

    Reason

    Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.

    Action

    On 7/1/2025, recall notices were emailed to customers who were asked to do the following: 1) Quarantine the junctional emergency treatment tools. 2) Discontinue use and distribution. 3) Complete and return the response form via email to [email protected] In addition, if you have further distributed affected products, identify your customers and notify them of this recall. Your notification to your customers may be enhanced by including a copy of the recall notice. Instruct your customers to return affected product to you and then you will coordinate return with the recalling firm. This recall should be carried out to the user level. If you have questions contact the firm's customer service at 1-888-689-6277

    Distribution

    Worldwide - US Nationwide distribution in the states of SC, OK, ID, KY, VA, NV, IL, TX, CA, FL, LA, NY, LA, ME, PA, AR, AZ, AL, DE, MA, MS, HI, WA, MI, GA, NJ, UT, MD, OR, NC, NC, AL and the countries of KOR, JPN, BWA, SAU, BEL.

    Quantity

    552