Z-2789-2020Class II

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

Name: Z-2789-2020 STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal...
Creator: HF Acquisition Co., LLC
Published: 2020-06-04
License: https://open.fda.gov/license/

HF Acquisition Co. LLC / initiated 2020-06-04 / Terminated / root cause: packaging

FDA source

HF Acquisition Co., LLC began a recall of STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300 on 2020-06-04. FDA classified it as Class II and gives the reason as "Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2789-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-04
Posted: 2020-08-12
Terminated: 2022-07-08
Recalling firm: HF Acquisition Co. LLC
Product: STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300
Product code: LRR First Aid Kit With Drug
Reason for recall: Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.
Root cause tag: packaging
FDA root cause: Process change control
Action: On June 4th, 2020, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification to customers via UPS Priority Overnight, informing them that their emergency medical kits supplied had missing nasal spray vial inside the kit. The notification informed the customers that the Recalling Firm is supplying the 2 doses of nasal spray along with instructions to add the nasal doses to their Emergency Medical Kits and if the customer wished to return the single dose for destruction.to the firm, send in a postage paid Unused Medications Recovery Envelop. The notification included, firm's Customer Support team will call customers, following the acknowledgement of this notice and replacement product to confirm that the (2) Doses of Nasal Sprays have been placed into your Emergency Medical Kit. For any questions or information contact the Recalling Firm at 1-800-331-1984.
Quantity in commerce: 95 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
Product codes and lots: STAT KIT¿ SM30 ; Emergency Medical Kit P/N: 1008670 Narcan Nasal spray, item number 1010300

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2789-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2788-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12
Z-2789-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12
Z-2790-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12
Z-2791-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-12

Product code LRR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)