Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intr...

FDA Recall #Z-0003-2024 — Class I — August 10, 2023

Recall #Z-0003-2024 Date: August 10, 2023 Classification: Class I Status: Ongoing

Product Description

Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days

Reason for Recall

This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

Recalling Firm

ARROW INTERNATIONAL Inc. — Morrisville, NC

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

380 units

Distribution

US

Code Information

Batch/Lot number 13F22L0806

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated