Facility

GAMBRO INDUSTRIES

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

Key facts

3recalls · 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)	3002807204
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	7, AV. LIONEL TERRAY, B.P. 126 MEYZIEU CEDEX Rhone, FR 69883
Registration status	Active · expires 2026
Parent company	Vantive US Healthcare LLC (owner-operator 9038727)
Brand names	PRISMAFLEX M150 SET

Activity by year

Recalls (3)

Devices registered here (1)

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

Recalls & enforcement

Class IIOngoing2026-01-06
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class IIOngoing2025-08-28
Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may thin…
Class IIOngoing2025-07-28
Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted

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. “GAMBRO INDUSTRIES (FEI 3002807204) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807204-gambro-industries/

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