BEUDAMED
    FDA Enforcement Class II Terminated

    HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300

    Recall: Z-2788-2020 · Reported August 19, 2020

    Enforcement

    Recall Number
    Z-2788-2020
    Event ID
    85911
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    HF Acquisition Co., LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2020
    Initiation Date
    June 4, 2020
    Classification Date
    August 12, 2020
    Termination Date
    July 8, 2022
    Address
    11629 49th Pl W, N/A, Mukilteo, WA, 98275-4255, United States

    Description

    HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300

    Reason

    Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.

    Code Info

    SM7 (NARCAN Upgrade Bundle): P/N: 1008150 SM7 Emergency Medical Kit

    Distribution

    U.S. Distribution: CA, FL, NY, AL, WA, CT, OH, MA, TX, NH, WI, ID, MN, DC, IL, MI, PA, MT, AK, NE, MD, CO, GA, VA, WY, MO, HI, SD, AR, TN, KS, ND, WV, NJ, OK, OR, ME, AZ, NC, OUS: None

    Quantity

    2 kits of SM 7