Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow ...
FDA Recall #Z-0001-2024 — Class I — August 10, 2023
Product Description
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 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
1173 units
Distribution
US
Code Information
Batch/Lot number 33F23B0781
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated