FEI 3002806457
Fenwal International, Inc.
CARRETERA SANCHEZ KM 18.5, HAINA San Cristobal, DO
MDR events81All time
Recalls0All time
Registered products21
Establishment typeManufactureManufacture Medical Device
Registered product codes
21 product codes
Recent MDR events
81 on file
- FRESENIUS COM.TEC AUTOMATED CELL SEPARATORJul 1, 2026Injury3004548776-2026-00296
- FRESENIUS COM.TEC AUTOMATED CELL SEPARATORJul 1, 2026Injury3004548776-2026-00295
- IVENIX, INC.Jun 11, 2026Malfunction3014732157-2026-02863
- PLASMACELL XI DISPOSABLE SET WITH SPIKESMARTJun 5, 2026Malfunction3004548776-2026-00251
- PLASMACELL XI DISPOSABLE SET WITH SPIKESMARTJun 4, 2026Malfunction3004548776-2026-00244
- PLASMACELL XI DISPOSABLE SET WITH SPIKESMARTMar 31, 2026Malfunction3004548776-2026-00137
- PLASMACELL XI DISPOSABLE SET WITH SPIKESMARTFeb 24, 2026Injury3004548776-2026-00062
- FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEMFeb 23, 2026Death3004548776-2026-00049
- AMICUS DOUBLE NEEDLE ADVANCED KIT WITH PLATELET ADDITIVE SOLUTION CONNECTORDec 10, 2025Malfunction3004548776-2025-00605
- FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEMNov 24, 2025Death3004548776-2025-00604
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3002806457.
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
0 on file
No import refusals on file for this FEI number.