Facility

HF Acquisition Co. LLC

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3014534
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device
Location	11629 49th Place W Mukilteo, WA, US 98275
Registration status	Active · expires 2026
Parent company	HF ACQUISITION CO. LLC (owner-operator 3014534)
Brand names	Stat Kit Z-1000 Emergency Medical Kit (Z1000-01.1); Criti-Kit CK200 Emergency Response Kit; Mobile ACLS Emergency Medical Kit; Stat Kit 550 Emergency Medical Kit; STAT KIT® Pedi - Intubation Emergency Medical Kit; SM Organizer Emergency Medical Kit; STAT KIT® Pedi Emergency Medical Kit; Mobile ACLS V2 Emergency Medical Kit; STAT KIT 550 AI Emergency Medical Kit; SM27 Select Emergency Medical Kit; SM7 Select Emergency Medical Kit; SM30 Emergency Medical Kit

Activity by year

Recalls (4)

Devices registered here (1)

First Aid Kit With Drug
Product code LRR (opens in a new tab) · Not classified · Unknown

Recalls & enforcement

Class IIOngoing2026-04-13
Due to incorrect incubation process being performed on product.
Class IIOngoing2024-12-11
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
Class IITerminated2020-06-05
A missing component (hand suction pump) in the emergency medical kits.
Class IITerminated2020-06-04
Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits.

All facilities operated by HF ACQUISITION CO. LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HF Acquisition Co. LLC (FEI 3014534) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014534-hf-acquisition-co-llc/

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