Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow...
FDA Recall #Z-0004-2024 — Class I — August 10, 2023
Product Description
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 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
172 units
Distribution
US
Code Information
Batch/Lot number 13F22G0508
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated