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Recall Observatory FDA recall evidence

Device product

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

Z-2789-2020

June 04, 2020

Class II

Product summary

Firm
HF Acquisition Co., LLC
Event
Event 85911
Status
Terminated
Classification
Class II
Quantity
95 Kits
Official record key
device-enforcement:Z-2789-2020

Official wording

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

Code information: STAT KIT¿ SM30 ; Emergency Medical Kit P/N: 1008670 Narcan Nasal spray, item number 1010300

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.