Medical device recalls Moderate risk

HF Acquisition Co., LLC recalls STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, ite…

Recall date
June 4, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2791-2020
FDA classification
Class II
Brand / firm
HF Acquisition Co., LLC
Sold / distributed
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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300

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