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ARROW INTERNATIONAL Inc.

353 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Sprin recall (Z-3299-2024)ARROW INTERNATIONAL Inc.2024-09-26
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840 recall (Z-1878-2024)ARROW INTERNATIONAL Inc.2024-06-03
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; recall (Z-1879-2024)ARROW INTERNATIONAL Inc.2024-06-03
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840- recall (Z-1880-2024)ARROW INTERNATIONAL Inc.2024-06-03
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF recall (Z-1267-2024)ARROW INTERNATIONAL Inc.2024-03-21
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with recall (Z-0001-2024)ARROW INTERNATIONAL Inc.2023-10-05
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC- recall (Z-0002-2024)ARROW INTERNATIONAL Inc.2023-10-05
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter recall (Z-0003-2024)ARROW INTERNATIONAL Inc.2023-10-05
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded wit recall (Z-0004-2024)ARROW INTERNATIONAL Inc.2023-10-05
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravas recall (Z-2590-2023)ARROW INTERNATIONAL Inc.2023-09-15
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF C recall (Z-2591-2023)ARROW INTERNATIONAL Inc.2023-09-15
ARROW Endurance Extended Dwell Peripheral Catheter System recall (Z-1826-2023)ARROW INTERNATIONAL Inc.2023-06-21
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardia recall (Z-0426-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN00 recall (Z-0427-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac recall (Z-0428-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac recall (Z-0429-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000 recall (Z-0430-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), ca recall (Z-0431-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IP recall (Z-0432-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), card recall (Z-0433-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), card recall (Z-0434-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), card recall (Z-0435-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardi recall (Z-0436-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardi recall (Z-0437-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN00 recall (Z-0438-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917 recall (Z-0439-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN91 recall (Z-0440-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN00 recall (Z-0441-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN91 recall (Z-0442-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN91 recall (Z-0443-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305) recall (Z-0444-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306) recall (Z-0445-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308) recall (Z-0446-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN0 recall (Z-0447-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN0 recall (Z-0448-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN recall (Z-0449-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN0 recall (Z-0450-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN0 recall (Z-0451-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN0 recall (Z-0452-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN recall (Z-0453-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN recall (Z-0454-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN0 recall (Z-0455-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN0 recall (Z-0456-2023)ARROW INTERNATIONAL Inc.2022-12-15
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11 recall (Z-0351-2023)ARROW INTERNATIONAL Inc.2022-12-10
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS recall (Z-0352-2023)ARROW INTERNATIONAL Inc.2022-12-10
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .0 recall (Z-0102-2023)ARROW INTERNATIONAL Inc.2022-10-19
Arrow Three-Lumen CVC recall (Z-1290-2022)ARROW INTERNATIONAL Inc.2022-06-27
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: recall (Z-0231-2022)Arrow International Inc2021-11-18
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: recall (Z-0232-2022)Arrow International Inc2021-11-18
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: recall (Z-0233-2022)Arrow International Inc2021-11-18
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: recall (Z-0234-2022)Arrow International Inc2021-11-18
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Prod recall (Z-1374-2021)Arrow International Inc2021-04-07
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 recall (Z-2408-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH, Product Code IAP-0400E recall (Z-2409-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE, Product Code IAP-0500 recall (Z-2410-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E recall (Z-2411-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I recall (Z-2412-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J recall (Z-2413-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL recall (Z-2414-2020)Arrow International Inc2020-06-26
Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535 recall (Z-2415-2020)Arrow International Inc2020-06-26
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-070 recall (Z-2416-2020)Arrow International Inc2020-06-26
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-070 recall (Z-2417-2020)Arrow International Inc2020-06-26
FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B recall (Z-1170-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Set, Product Code AA-05400-E recall (Z-1171-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501 recall (Z-1172-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B recall (Z-1173-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH recall (Z-1174-2020)Arrow International Inc2020-01-24
TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1 recall (Z-1175-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05500-TM recall (Z-1176-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500 recall (Z-1177-2020)Arrow International Inc2020-01-24
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID recall (Z-1178-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05400-CA1 recall (Z-1179-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05501-SH recall (Z-1180-2020)Arrow International Inc2020-01-24
Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product C recall (Z-1181-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID recall (Z-1182-2020)Arrow International Inc2020-01-24
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1 recall (Z-1183-2020)Arrow International Inc2020-01-24
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH recall (Z-1184-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC recall (Z-1185-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO recall (Z-1186-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN recall (Z-1187-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL recall (Z-1188-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH recall (Z-1189-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO recall (Z-1190-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-BXL recall (Z-1191-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH recall (Z-1192-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220 recall (Z-1193-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI recall (Z-1194-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO recall (Z-1195-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC- recall (Z-1196-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04 recall (Z-1197-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10 recall (Z-1198-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12 recall (Z-1199-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code IT-05400-DC recall (Z-1200-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B recall (Z-1201-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS recall (Z-1202-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E recall (Z-1203-2020)Arrow International Inc2020-01-24
EPIDURAL CATHETERIZATION KIT, Product Code JC-05400-LB recall (Z-1204-2020)Arrow International Inc2020-01-24
10 cc Luer-Slip Loss of Resistance Syringe, Product Code LR-05501 recall (Z-1205-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Set, Product Code MP-17019-TIP recall (Z-1206-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP recall (Z-1207-2020)Arrow International Inc2020-01-24
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Every clearance here is in the API, with alerts when new ones post.