FEI 3002806443
Baxter Healthcare, S.a.
Parque Industrial ITABO, Haina San Cristobal, DO
MDR events28All time
Recalls0All time
Registered products13
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
13 product codes
Recent MDR events
28 on file
- BAXTER HEALTHCARE PRISMAX CRRT FILTERMar 26, 2026InjuryMW5185911
- PRISMAFLEX ST 150Mar 20, 2026MalfunctionMW5185513
- PRISMAFLEX ST 150Mar 20, 2026MalfunctionMW5185514
- PRISMAFLEX ST 150Mar 20, 2026MalfunctionMW5185515
- PRIMAX THERMAX BLOOD WARMERMar 5, 2026InjuryMW5184793
- CRRT FILTER SETFeb 19, 2026MalfunctionMW5184075
- CRRT FILTER SETFeb 19, 2026MalfunctionMW5184076
- CRRT FILTER SETFeb 19, 2026MalfunctionMW5184077
- PRISMAFLEX HF 1000 FILTER SETDec 8, 2025MalfunctionMW5180138
- PD CATHETER/ LIBERTY SELECT CYCLERNov 28, 2025MalfunctionMW5179485
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3002806443.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
5 on file
Top refusal reasons
Compare to industry ↗- Division of Northeast Imports (DNEI)Jul 7, 2026
80FPA \ SET, ADMINISTRATION, INTRAVASCULAR
- Division of Northeast Imports (DNEI)Jul 7, 2026
80FPA \ SET, ADMINISTRATION, INTRAVASCULAR
- Division of Northeast Imports (DNEI)Jul 7, 2026
80FMG \ STOPCOCK, I.V. SET
- Division of Northeast Imports (DNEI)Jul 7, 2026
80FPA \ SET, ADMINISTRATION, INTRAVASCULAR
- Division of Northeast Imports (DNEI)Jul 7, 2026
80KPE \ CONTAINER, I.V.