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ARROW INTERNATIONAL Inc.

FDA Regulatory Profile

Summary

Total Recalls
525 (96 Class I)
510(k) Clearances
22
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2364-2026Class IDescription/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G April 21, 2026
Z-2383-2026Class IDescription/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGUApril 21, 2026
Z-2390-2026Class IDescription/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SApril 21, 2026
Z-2366-2026Class IDescription/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PApril 21, 2026
Z-2374-2026Class IDescription/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-PApril 21, 2026
Z-2370-2026Class IDescription/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR XApril 21, 2026
Z-2391-2026Class IDescription/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; April 21, 2026
Z-2395-2026Class IDescription/REF: PICC ACCESS TRAY/ASK-04001-CG1April 21, 2026
Z-2372-2026Class IDescription/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1AApril 21, 2026
Z-2377-2026Class IDescription/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04April 21, 2026
Z-2385-2026Class IDescription/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSIApril 21, 2026
Z-2371-2026Class IDescription/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT:April 21, 2026
Z-2386-2026Class IDescription/REF: PARACENTESIS KIT/ASK-00376-JHHApril 21, 2026
Z-2392-2026Class IDescription/REF: ACCESS TRAY/ASK-04001-MC3April 21, 2026
Z-2378-2026Class IDescription/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-4455April 21, 2026
Z-2376-2026Class IDescription/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-1April 21, 2026
Z-2375-2026Class IDescription/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGBApril 21, 2026
Z-2388-2026Class IDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-April 21, 2026
Z-2393-2026Class IDescription/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSUApril 21, 2026
Z-2369-2026Class IDescription/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CApril 21, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K250542AC3™ Range™ Intra-Aortic Balloon PumpMarch 26, 2025
K232343AC3™ Series IABPAugust 30, 2023
K222341Arrow 0.2 Micron Flat Filter, GVSFebruary 13, 2023
K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPMay 27, 2020
K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitApril 9, 2020
K190101UltraFlex IABJune 28, 2019
K190117Fiberoptix IABJune 13, 2019
K162820AC3 Series IABP SystemMarch 31, 2017
K141051VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROJuly 7, 2014
K130192NEXTSTEP RETROGRADEMay 10, 2013
K130876CG+ ARROW PICC POWERED BY ARROW VPS STYLETApril 26, 2013
K122690ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLEDecember 21, 2012
K122027ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETERAugust 28, 2012
K113277ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITSJune 21, 2012
K080604PRESSURE INJFECTABLE PICCJune 27, 2008
K073451PRESSURE INJECTABLE PICCJanuary 15, 2008
K071538ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETERAugust 30, 2007
K061289ARROW PRESSURE INJECTABLE PICCAugust 24, 2006
K041740SILICONE COATED GUIDEWIREOctober 15, 2004
K040666STEP-TIP CHRONIC HEMODIALYSIS CATHETERMay 14, 2004