Facility

METRIX DOMINICANA S.R.L.

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

Key facts

4recalls · 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)	3004102635
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	PARQUE INDUSTRIAL ITABO, S.A. (PIISA) HAINA San Cristobal, DO --
Registration status	Active · expires 2026
Parent company	The Metrix Company (owner-operator 1937141)
Brand names	HCT

Activity by year

Recalls (4)

Devices registered here (1)

Container, I.V.
Product code KPE (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5025

Recalls & enforcement

Class IIOngoing2024-10-09
A limited number of IV bags have been found to leak during filling.
Class IIOngoing2018-09-21
Potential for leaking product
Class IITerminated2017-09-13
The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.
Class IITerminated2016-06-23
An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly…

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. “METRIX DOMINICANA S.R.L. (FEI 3004102635) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004102635-metrix-dominicana-s-r-l/

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