Facility

PRIMUS STERILIZER COMPANY, LLC.

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

Key facts

2recalls · worst Class II

2inspections · worst VAI

—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)	1000119270
Establishment type	Manufacture Medical Device
Location	175 N US HWY 281 Great Bend, KS, US 67530
Registration status	Active · expires 2026
Parent company	Primus (owner-operator 9005293)
Brand names	Sterilizer,steam

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Sterilizer, Steam
Product code FLE (opens in a new tab) · Class II · General Hospital · 21 CFR 880.6880

Recalls & enforcement

Class IIITerminated2021-10-05
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further te…
Class IITerminated2020-10-09
The product did not receive pre-market approval or clearance.

FDA inspections (2)

NAI2018-03-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2017-02-21
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “PRIMUS STERILIZER COMPANY, LLC. (FEI 1000119270) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000119270-primus-sterilizer-company-llc/

Not open yet

Alerts for PRIMUS STERILIZER COMPANY, LLC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.