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ARROW INTERNATIONAL Inc.

353 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue recall (Z-2492-2010)Arrow International Inc2010-09-25
Two-Lumen Central Venous Catheterization kit with Blue FlexTip ARROW g+ard Blue PLUS Cathe recall (Z-2493-2010)Arrow International Inc2010-09-25
Arterial Catheterization Set recall (Z-2494-2010)Arrow International Inc2010-09-25
Femoral Artery Catheterization Set recall (Z-2495-2010)Arrow International Inc2010-09-25
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter recall (Z-2496-2010)Arrow International Inc2010-09-25
Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use recall (Z-2274-2010)Arrow International Inc2010-08-25
Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451- recall (Z-1682-2010)Arrow International Inc2010-05-26
Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use recall (Z-1538-2010)Arrow International Inc2010-05-05
IV Sets and Accessories, various configurations. An Intravenous Administration Tubing set recall (Z-1112-2010)Arrow International Inc2010-03-30
Y-Type Blood Pump Sets, with Detachable Polysulfone Stopcock. For Veterinary Use Only and recall (Z-1113-2010)Arrow International Inc2010-03-30
IV Extension Set with Spike and 2-Way Stopcock. An Intravenous Administration Tubing set i recall (Z-1114-2010)Arrow International Inc2010-03-30
15 Drop IV Sets, with Retractable Luer-Lock and with Smartsite(TM) Y-Injection sites and 4 recall (Z-1115-2010)Arrow International Inc2010-03-30
Non-Vented IV Set with 2-Gang "Hi-Flo" Stopcocks with Luer Activated HEP Lock Valves and L recall (Z-1116-2010)Arrow International Inc2010-03-30
Positive Pressure Blood Pump Sets, with Stopcock and Smartsite(TM) Y-Injection Site and wi recall (Z-1117-2010)Arrow International Inc2010-03-30
60 Drop IV Set with SmartSite(TM) Y-Injection Sites, 2-Gang Standard Bore Stopcocks and T- recall (Z-1118-2010)Arrow International Inc2010-03-30
150ML Burette IV Set with SmartSite(TM) Y-Injection Site, 2-Gang Standard Bore Stopcocks a recall (Z-1119-2010)Arrow International Inc2010-03-30
20 Drop IV Set with 3 SmartSite(TM) Y-Injection Sites, 2-Gang 4-Way Stopcock and Novex Sto recall (Z-1120-2010)Arrow International Inc2010-03-30
8" Microbore Extension with Detachable SmartSite(TM) HEP-Lock and Retractable Spinning Lue recall (Z-1121-2010)Arrow International Inc2010-03-30
IV Set with Two SmartSite(TM) Y-Injection Sites, Stopcock and 3-Gang Pressure Activated Ma recall (Z-1122-2010)Arrow International Inc2010-03-30
8" Extension Set with SmartSite(TM) HEP-Lock and Rotating Luer Lock. SmartSite(TM) is a tr recall (Z-1123-2010)Arrow International Inc2010-03-30
10 Drop IV Sets, with 3 Pre-Pierced Y-Injection Sites and 3-Gang Pressure Activated Manifo recall (Z-1124-2010)Arrow International Inc2010-03-30
Y-Type Positive Pressure Pump Set with 2-Gang 4-Way Stopcock and Detachable 4-Way Stopcock recall (Z-1125-2010)Arrow International Inc2010-03-30
7" Non-Kink Extension Set with Rotating Luer-Lock Connector. An Intravenous Administration recall (Z-1126-2010)Arrow International Inc2010-03-30
Positive Pressure Blood Pumps, with Pre-Pierced Y-Injection Site; with Three SmartSite(TM) recall (Z-1127-2010)Arrow International Inc2010-03-30
Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activ recall (Z-1128-2010)Arrow International Inc2010-03-30
4-Way "Hi-Flo" Extension Set with Two SmartSite(TM) Y-Injection Sites and Rotating Luer Lo recall (Z-1129-2010)Arrow International Inc2010-03-30
Burette Set with SmartSite(TM) Y-Injection Site and SmartSite(TM) HEP-Lock on Burette Smar recall (Z-1130-2010)Arrow International Inc2010-03-30
MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integ recall (Z-0783-2010)Arrow International Inc2010-03-05
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Va recall (Z-0784-2010)Arrow International Inc2010-03-05
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS recall (Z-0785-2010)Arrow International Inc2010-03-05
Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS ( recall (Z-0786-2010)Arrow International Inc2010-03-05
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS recall (Z-0787-2010)Arrow International Inc2010-03-05
Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS recall (Z-0788-2010)Arrow International Inc2010-03-05
12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, C recall (Z-1671-2009)Arrow International Inc2009-08-10
12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, A recall (Z-1672-2009)Arrow International Inc2009-08-10
Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 recall (Z-1653-2009)Arrow International Inc2009-07-07
Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single use, recall (Z-1471-2009)Arrow International Inc2009-06-25
Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, recall (Z-1472-2009)Arrow International Inc2009-06-25
Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single use, recall (Z-1473-2009)Arrow International Inc2009-06-25
Arrow 4way Hi-Flo Stopcock with male luer lock, latex free used in various IV kits. recall (Z-1489-2009)Arrow International Inc2009-06-24
Arrow Extension sets and accessories for intravascular use. recall (Z-1490-2009)Arrow International Inc2009-06-24
Arrow Super Arrow-Flex Percutaneous Sheath Introducers recall (Z-1491-2009)Arrow International Inc2009-06-24
Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers recall (Z-1492-2009)Arrow International Inc2009-06-24
Arrow Percutaneous Sheath Introducers recall (Z-1493-2009)Arrow International Inc2009-06-24
Arrow Single Lumen CVCs (Central Venous Catheters) recall (Z-1494-2009)Arrow International Inc2009-06-24
Arrow Multi-Lumen CVC w/ BlueFlex Tip (Central Venous Catheter) recall (Z-1495-2009)Arrow International Inc2009-06-24
Arrow Two-Lumen Central Venous Access (MAC) recall (Z-1496-2009)Arrow International Inc2009-06-24
Arrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters) recall (Z-1497-2009)Arrow International Inc2009-06-24
Arrow ARROWg+ard Blue Plus Multi-Lumen CVCs (Central Venous Catheters) recall (Z-1498-2009)Arrow International Inc2009-06-24
Arrow ARROWg+ard CVCs (Central Venous Catheters) recall (Z-1499-2009)Arrow International Inc2009-06-24
Arrow Balloon and stylet temporary pacing catheter recall (Z-1500-2009)Arrow International Inc2009-06-24
Arrow Percutaneous Thrombolytic Device (PTD) for fistula and dialysis grafts recall (Z-1501-2009)Arrow International Inc2009-06-24
Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts recall (Z-1502-2009)Arrow International Inc2009-06-24
Arrow Peripherally Inserted Central Catheter recall (Z-1503-2009)Arrow International Inc2009-06-24
8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, recall (Z-1210-2009)Arrow International, Inc.2009-04-16
8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, recall (Z-1211-2009)Arrow International, Inc.2009-04-16
8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloo recall (Z-1212-2009)Arrow International, Inc.2009-04-16
8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The Intra-aortic balloo recall (Z-1213-2009)Arrow International, Inc.2009-04-16
7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic ba recall (Z-1214-2009)Arrow International, Inc.2009-04-16
7.5 Fr 40cc UltraFlex IAB, IAB-06840-U, Intra-aortic balloon catheter. The Intra-aortic ba recall (Z-1215-2009)Arrow International, Inc.2009-04-16
8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic b recall (Z-1216-2009)Arrow International, Inc.2009-04-16
8 Fr 40cc FIBEROPTIX IAB, IAB-05840-LWS, Intra-aortic balloon catheter. The Intra-aortic b recall (Z-1217-2009)Arrow International, Inc.2009-04-16
7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloo recall (Z-1218-2009)Arrow International, Inc.2009-04-16
8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloo recall (Z-1219-2009)Arrow International, Inc.2009-04-16
9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic ballo recall (Z-1220-2009)Arrow International, Inc.2009-04-16
ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic recall (Z-1221-2009)Arrow International, Inc.2009-04-16
ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic recall (Z-1222-2009)Arrow International, Inc.2009-04-16
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242, Inten recall (Z-2242-2008)Arrow International Inc2008-09-17
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282, Inten recall (Z-2243-2008)Arrow International Inc2008-09-17
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322, Inten recall (Z-2244-2008)Arrow International Inc2008-09-17
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362, Inten recall (Z-2245-2008)Arrow International Inc2008-09-17
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552, Inten recall (Z-2246-2008)Arrow International Inc2008-09-17
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CSD-15242, Inte recall (Z-2247-2008)Arrow International Inc2008-09-17
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CSD-15282, Inte recall (Z-2248-2008)Arrow International Inc2008-09-17
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CSD-15322, Inte recall (Z-2249-2008)Arrow International Inc2008-09-17
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CSD-15362, Inte recall (Z-2250-2008)Arrow International Inc2008-09-17
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CSD-15552, Inte recall (Z-2251-2008)Arrow International Inc2008-09-17
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242-SP, Intend recall (Z-2252-2008)Arrow International Inc2008-09-17
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-SP, Intend recall (Z-2253-2008)Arrow International Inc2008-09-17
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322-SP, Intend recall (Z-2254-2008)Arrow International Inc2008-09-17
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362-SP, Intend recall (Z-2255-2008)Arrow International Inc2008-09-17
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-SP, Intend recall (Z-2256-2008)Arrow International Inc2008-09-17
Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242-VSP, Intend recall (Z-2257-2008)Arrow International Inc2008-09-17
Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-VSP, Intend recall (Z-2258-2008)Arrow International Inc2008-09-17
Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322-VSP, Intend recall (Z-2259-2008)Arrow International Inc2008-09-17
Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362-VSP, Intend recall (Z-2260-2008)Arrow International Inc2008-09-17
Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-VSP, Intend recall (Z-2261-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to recall (Z-2262-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to recall (Z-2263-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to recall (Z-2264-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to recall (Z-2265-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to recall (Z-2266-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, C recall (Z-2267-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, C recall (Z-2268-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, C recall (Z-2269-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, C recall (Z-2270-2008)Arrow International Inc2008-09-17
ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff t recall (Z-2271-2008)Arrow International Inc2008-09-17
ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff t recall (Z-2272-2008)Arrow International Inc2008-09-17
ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff t recall (Z-2273-2008)Arrow International Inc2008-09-17
ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff t recall (Z-2274-2008)Arrow International Inc2008-09-17
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