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Recall Observatory FDA recall evidence

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

Z-2788-2020

June 04, 2020

Class II

Product summary

Firm
HF Acquisition Co., LLC
Event
Event 85911
Status
Terminated
Classification
Class II
Quantity
2 kits of SM 7
Official record key
device-enforcement:Z-2788-2020

Official wording

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

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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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