Facility

XVIVO BV

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

Key facts

1recalls · 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)	3021739803
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	Bornholmstraat 84 Groningen, NL 9723 AZ
Registration status	Active · expires 2026
Parent company	XVIVO Perfusion AB (owner-operator 10029831)
Brand names	Kidney Assist Transport; Kidney Assist Transport Perfusion Set

Activity by year

Recalls (1)

Devices registered here (1)

System, Perfusion, Kidney
Product code KDN (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5880

Recalls & enforcement

Class IITerminated2022-04-08
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.

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. “XVIVO BV (FEI 3021739803) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021739803-xvivo-bv/

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