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 I: 4, Class II: 1.
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.
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.