Facility

Baja Fur S.A. de C.V.

5 recall(s) on record — most severe on record: Class I.

Key facts

5recalls · worst Class I

—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)	3038138522
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	Blv. Agua Caliente 8582-5 Tijuana BC. Baja California, MX 22000
Registration status	Active · expires 2026
Parent company	Outset Medical, Inc. (owner-operator 10047467)
Brand names	Tablo Hemodialysis System

Activity by year

Recalls (5)

Devices registered here (2)

Dialyzer, High Permeability With Or Without Sealed Dialysate System
Product code KDI (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5860
Subsystem, Water Purification
Product code FIP (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5665

Recalls & enforcement

Class IIOngoing2024-08-01
Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experien…
Class IIOngoing2024-04-30
A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke, melting or charring (thermal event) of the female connector or t…
Class IOngoing2024-03-06
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PC…
Class IIOngoing2023-01-24
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
Class IIOngoing2022-01-20
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

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 3038138522) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3038138522-baja-fur-s-a-de-c-v/

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