Home / Recalls / Vascular Insights, LLC / Z-1146-2018

Z-1146-2018 Class II Terminated

Recalled by Vascular Insights, LLC — Quincy, MA

Recall Details

Product Type: Devices
Report Date: March 28, 2018
Initiation Date: November 9, 2017
Termination Date: December 18, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 928

Product Description

ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.

Reason for Recall

Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.

Distribution Pattern

U.S Nationwide in the states: AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MO, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA

Code Information

Lot number: BM651403017I