FDA-Device2020-08-19Class II

STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300

HF Acquisition Co., LLC
Hazard

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

Sold states
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
Affected count
95 Kits
Manufactured in
11629 49th Pl W, N/A, Mukilteo, WA, United States
Products
STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2789-2020

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