Medical DeviceOct 2, 2024
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" recall — FDA Z-3299-2024
Reports have been received regarding open seals on the packaging.
Class IIFDA: OngoingARROW INTERNATIONAL Inc.
Recall history in this database
Classification mix: Class II: 319, Class I: 24.
Medical DeviceJun 12, 2024
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS recall — FDA Z-1878-2024
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as:…
Class IFDA: OngoingARROW INTERNATIONAL Inc.
Medical DeviceJun 12, 2024
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U recall — FDA Z-1879-2024
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as:…
Class IFDA: OngoingARROW INTERNATIONAL Inc.
Medical DeviceJun 12, 2024
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U recall — FDA Z-1880-2024
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as:…
Class IFDA: OngoingARROW INTERNATIONAL Inc.
Medical DeviceMar 27, 2024
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF recall — FDA Z-1267-2024
Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to…
Class IFDA: OngoingARROW INTERNATIONAL Inc.
Medical DeviceOct 11, 2023
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with recall — FDA Z-0004-2024
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Class IFDA: OngoingARROW INTERNATIONAL Inc.
Medical DeviceOct 11, 2023
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF recall — FDA Z-0002-2024
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Class IFDA: OngoingARROW INTERNATIONAL Inc.
Medical DeviceOct 11, 2023
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with recall — FDA Z-0001-2024
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Class IFDA: OngoingARROW INTERNATIONAL Inc.
Medical DeviceOct 11, 2023
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A recall — FDA Z-0003-2024
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Class IFDA: OngoingARROW INTERNATIONAL Inc.
Medical DeviceSep 27, 2023
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF recall — FDA Z-2591-2023
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Class IIFDA: OngoingARROW INTERNATIONAL Inc.
Medical DeviceDec 21, 2022
ARROW INTERNATIONAL Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF recall — FDA Z-0352-2023
There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and…
Class IFDA: TerminatedARROW INTERNATIONAL Inc.
Medical DeviceDec 21, 2022
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF recall — FDA Z-0351-2023
There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and…
Class IFDA: TerminatedARROW INTERNATIONAL Inc.
Medical DeviceOct 26, 2022
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 recall — FDA Z-0102-2023
Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming…
Class IIFDA: TerminatedARROW INTERNATIONAL Inc.
Medical DeviceNov 24, 2021
Arrow International Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device recall — FDA Z-0233-2022
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of…
Class IFDA: TerminatedArrow International Inc.
Medical DeviceNov 24, 2021
Arrow International Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device recall — FDA Z-0234-2022
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of…
Class IFDA: TerminatedArrow International Inc.
Medical DeviceNov 24, 2021
Arrow International Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device recall — FDA Z-0232-2022
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of…
Class IFDA: TerminatedArrow International Inc.
Medical DeviceNov 24, 2021
Arrow International Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device recall — FDA Z-0231-2022
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of…
Class IFDA: TerminatedArrow International Inc.
Medical DeviceJul 21, 2021
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 recall — FDA Z-2068-2021
Marketed without a 510K
Class IIFDA: OngoingArrow International Inc.
Medical DeviceJul 21, 2021
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product recall — FDA Z-2069-2021
Marketed without a 510K
Class IIFDA: OngoingArrow International Inc.
Medical DeviceJul 21, 2021
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product recall — FDA Z-2070-2021
Marketed without a 510K
Class IIFDA: OngoingArrow International Inc.
Medical DeviceJul 21, 2021
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product recall — FDA Z-2071-2021
Marketed without a 510K
Class IIFDA: OngoingArrow International Inc.
Medical DeviceApr 14, 2021
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy recall — FDA Z-1374-2021
Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate…
Class IIFDA: OngoingArrow International Inc.
Medical DeviceFeb 17, 2021
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central recall — FDA Z-1106-2021
The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceAug 19, 2020
Arrow International Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use recall — FDA Z-2802-2020
The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection…
Class IIFDA: TerminatedArrow International Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Arrow International Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.