BEUDAMED
    FDA Recall Terminated

    STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300

    Recall: Z-2790-2020 · Initiated June 4, 2020

    Recall

    Recall Number
    Z-2790-2020
    Event Number
    85911
    Firm
    HF Acquisition Co., LLC
    FEI Number
    3014534
    Product Code
    LRR
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 4, 2020
    Posted
    August 12, 2020
    Terminated
    July 8, 2022
    Address
    11629 49th Pl W, Mukilteo, WA, 98275-4255

    Description

    STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 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.

    Action

    On June 4th, 2020, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification to customers via UPS Priority Overnight, informing them that their emergency medical kits supplied had missing nasal spray vial inside the kit. The notification informed the customers that the Recalling Firm is supplying the 2 doses of nasal spray along with instructions to add the nasal doses to their Emergency Medical Kits and if the customer wished to return the single dose for destruction.to the firm, send in a postage paid Unused Medications Recovery Envelop. The notification included, firm's Customer Support team will call customers, following the acknowledgement of this notice and replacement product to confirm that the (2) Doses of Nasal Sprays have been placed into your Emergency Medical Kit. For any questions or information contact the Recalling Firm at 1-800-331-1984.

    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

    155