Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-3555...
FDA Recall #Z-2591-2023 — Class II — August 10, 2023
Product Description
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term 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 II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
177 units
Distribution
US Nationwide distribution.
Code Information
Batch/Lot number 13F22E0359
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated