Arrow International, Inc.
Arrow International, Inc. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2020, with 478 FDA device recalls on record.
Top product codes for Arrow International, Inc.
FDA recalls by Arrow International, Inc.
10 most recent of 478- Z-3299-2024 — Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.
- Z-1879-2024 — Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
- Z-1878-2024 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
- Z-1880-2024 — Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
- Z-1267-2024 — ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) REF NA-04220-S1A; j) REF NA-04220-X1A; k) REF RA-04220; l) REF RA-04220-W
- Z-2591-2023 — Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
- Z-2590-2023 — Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
- Z-0003-2024 — Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
- Z-0004-2024 — Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
- Z-0001-2024 — Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Arrow International, Inc.
- K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
- K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
- K190101 — UltraFlex IAB
- K190117 — Fiberoptix IAB
- K162820 — AC3 Series IABP System
- K141051 — VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU
- K130192 — NEXTSTEP RETROGRADE
- K130876 — CG+ ARROW PICC POWERED BY ARROW VPS STYLET
- K122690 — ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
- K122027 — ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
- K113277 — ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
- K080604 — PRESSURE INJFECTABLE PICC
- K073451 — PRESSURE INJECTABLE PICC
- K071538 — ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
- K061289 — ARROW PRESSURE INJECTABLE PICC
- K041740 — SILICONE COATED GUIDEWIRE
- K040666 — STEP-TIP CHRONIC HEMODIALYSIS CATHETER
- K040078 — CANNON II PLUS
- K030937 — STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
Data sourced from openFDA. This site is unofficial and independent of the FDA.