FDA recall Z-2788-2020

HF Acquisition Co., LLC · Class II · device

Product

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 for recall

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

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

Key facts

Status
Terminated
Initiation date
2020-06-04
Report date
2020-08-19
Termination date
2022-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mukilteo, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2788-2020