ARROW INTERNATIONAL Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 0 Recalls: 5

Known Identifiers & Locations

FEI Numbers 3013162291, 3015859709
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (5)

Recall # Product Description Initiation Date Status Action
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 Reason: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. 2023-08-10 Open, Classified View Details
Z-0002-2024 Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days Reason: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. 2023-08-10 Open, Classified View Details
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 Reason: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. 2023-08-10 Open, Classified View Details
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 Reason: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. 2023-08-10 Open, Classified View Details
Z-0030-2007 Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart. Reason: The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed. 2006-06-20 Terminated View Details

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