FEI 3013162291
Arrow International Llc (subsidiary Of Teleflex Incorporated)
3015 Carrington Mill Blvd., Morrisville, NC, US
MDR events203All time
Recalls0All time
Registered products27
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
27 product codes
Recent MDR events
203 on file
- ARROW FLEXTIP PLUS COMBINED SPINAL EPIDURAL TRAYJul 14, 2026MalfunctionMW5190731
- SUPER ARROW-FLEX(R) PERCUTANEOUS SHEATH INTRODUCER SETJul 7, 2026MalfunctionMW5190376
- PRESSURE INJECTABLE ARROWG+ARD BLUE PLUS THREE-LUMEN CVC KITJul 1, 2026InjuryMW5190183
- ARROW IABPJun 17, 2026MalfunctionMW5189541
- TERAFLEX IABPJun 9, 2026OtherMW5189051
- TERAFLEX IABPJun 9, 2026OtherMW5189052
- ARROW TELEFLEXJun 1, 2026MalfunctionMW5188768
- FIBEROPTIX IAB CATHETERMay 7, 2026MalfunctionMW5187863
- INTRA-AORTIC BALLOONMay 7, 2026InjuryMW5187874
- TELEFLEX FIBEROPTIX IABApr 29, 2026InjuryMW5187435
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3013162291.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Sep 8, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Sep 8, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.100(a)Sep 8, 2025
Lack of or inadequate procedures
- 21 CFR 820.100(b)Sep 8, 2025
Documentation
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.