Facility

Baja Fur S.A. de C.V.

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

Key facts

2recalls · 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)	3023209222
Establishment type	Manufacture Medical Device
Location	Calle Guerrero Negro 9965 Tijuana Baja California, MX 22643
Registration status	Active · expires 2026
Parent company	VAPOTHERM, INC. (owner-operator 9038880)
Brand names	HVT 2

Activity by year

Recalls (2)

Devices registered here (1)

Humidifier, Respiratory Gas, (Direct Patient Interface)
Product code BTT (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5450

Recalls & enforcement

Class IIOngoing2022-12-16
There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout.
Class IITerminated2014-08-13
Disposable Patient Circuit that allows water to leak into the center gas lumen

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. “Baja Fur S.A. de C.V. (FEI 3023209222) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3023209222-baja-fur-s-a-de-c-v/

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