Facility

RAND S.p.A.

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—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)	3003793891
Establishment type	Manufacture Medical Device
Location	VIA STATALE 12, 62 MEDOLLA Modena, IT 41036
Registration status	Active · expires 2026
Parent company	RAND S.p.A. (owner-operator 9063301)
Brand names	Ch24 round silicone catheter

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Catheter, Irrigation
Product code GBX (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4200

Recalls & enforcement

Class IITerminated2021-04-30
The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.

FDA inspections (1)

NAI2023-02-16
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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.

All facilities operated by RAND S.p.A.

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. “RAND S.p.A. (FEI 3003793891) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003793891-rand-s-p-a/

Not open yet

Alerts for RAND S.p.A.

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.