CLASS II Device recall · Reported 19 Aug 2020 · FDA Enforcement Report

STAT KIT recalled by HF Acquisition Co

HF Acquisition is recalling STAT KIT, distributed in 39 states. The recall was initiated on 4 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSTAT KIT¿ 550AI ; Emergency Medical Kit P/N: 1010830 Narcan Nasal spray item number 1010300

Quantity recalled5

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2791-2020
FDA event ID: 85911
Recalling firm: HF Acquisition, Mukilteo, WA
Classification: Class II
Status: Terminated
Recall initiated: 4 Jun 2020
FDA classified: 12 Aug 2020
Reported: 19 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

4 Jun 2020	Recall initiated by company
12 Aug 2020	Classified by FDA	+69 days
19 Aug 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was 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

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Hawaii Idaho Illinois Kansas Massachusetts Maryland Maine Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

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

Which lots are affected?

STAT KIT¿ 550AI ; Emergency Medical Kit P/N: 1010830 Narcan Nasal spray item number 1010300

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 85911

Reported	Class	Recall	Company	Reason	Where
19 Aug 2020	CLASS II	STAT KIT recalled by HF Acquisition Co	HF Acquisition	Packaging Defects	39 states
19 Aug 2020	CLASS II	STAT KIT recalled by HF Acquisition Co	HF Acquisition	Packaging Defects	39 states
19 Aug 2020	CLASS II	HealthFirst Emergency Medical Kit recalled by HF Acquisition Co	HF Acquisition	Packaging Defects	39 states

More recalls from HF Acquisition

All 10

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Device	CLASS II	Sporetraq Mail-in Spore Testing Service, 12 Tests recalled	HF Acquisition	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Sporetraq Mail-in Spore Testing Service, 52 Tests recalled	HF Acquisition	Device Malfunction	Nationwide
19 Feb 2025Device	CLASS II	Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests recalled	HF Acquisition	Sterility	50 states
14 Jun 2023Drug	CLASS III	Glycopyrrolate Injection, USP 0.2mg/ML Vial recalledGlycopyrrolate	HF Acquisition	Packaging Defects	AZ, CA, TX
19 Aug 2020Device	CLASS II	HealthFirst Emergency Medical Kit recalled by HF Acquisition Co	HF Acquisition	Packaging Defects	39 states

Other Other Medical Devices recalls

All 13,857

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Major Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide