Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854-...
FDA Recall #Z-0002-2024 — Class I — August 10, 2023
Product Description
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 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
180 units
Distribution
US
Code Information
Batch/Lot number 33F23B0723
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated