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U.S. Department of Health and Human Services

Class 2 Device Recall ClariVein IC infusion catheter

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  Class 2 Device Recall ClariVein IC infusion catheter see related information
Date Initiated by Firm November 09, 2017
Create Date March 21, 2018
Recall Status1 Terminated 3 on December 18, 2018
Recall Number Z-1146-2018
Recall Event ID 79324
510(K)Number K071468  
Product Classification Catheter, continuous flush - Product Code KRA
Product 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.
Code Information Lot number: BM651403017I
Recalling Firm/
Manufacturer		 Vascular Insights, LLC
1 Pine Hill Dr Ste 100
Quincy MA 02169-7485
For Additional Information Contact Lorraine M. Hanley
203-446-4593
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action Vascular Insights sent an Urgent Voluntary Medical Device Recall letter to their customers. The letter identified the affected product, problem and the actions to be taken. Customers were instructed to 1. Do not use or distribute any recalled product. 2. Immediately remove all recalled product from your inventory. 3. Segregate recalled product in a secure location and follow the instruction herein to return the recalled product and receive replacement product. 4. Immediately forward a copy of this recall notification to any/all sites to which you may have distributed the affected product and provide directions to follow the instructions contained herein. Customers were asked to complete and return the enclosed Reply Verification Tracking Form.
Quantity in Commerce 928
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = VASCULAR INSIGHTS LLC
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