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