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U.S. Department of Health and Human Services

Class 2 Device Recall Central Venous Tray Triple Lumen Polyurethane Catheter

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  Class 2 Device Recall Central Venous Tray Triple Lumen Polyurethane Catheter see related information
Date Initiated by Firm July 31, 2017
Create Date February 15, 2018
Recall Status1 Terminated 3 on May 08, 2019
Recall Number Z-0633-2018
Recall Event ID 79050
510(K)Number K173416  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT

Product Usage:
The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs
Code Information Lot Number (Expiration date): 5901462 (30-January-2018)
Recalling Firm/
Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Department
Manufacturer Reason
for Recall
Central venous catheters may not fit over guide wire potentially causing procedure delay.
FDA Determined
Cause 2
Process control
Action Cook sent an Urgent Medical Device Recall dated July 31, 2017 to affected customers. The letter identified the affected product problem and actions to be taken. The letter instructed customers to (1) Examine inventory immediately to determine if you have affected products and quarantine affected products. (2) Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. (3) Even if you do not have affected products on hand, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). (4) Complete and return the Acknowledgement and Receipt Form attached to this letter within 30 days. (5) Report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern time), or by email via CustomerRelationsNA@CookMedical.com.
Quantity in Commerce 50
Distribution Worldwide distribution - US Nationwide in the states of: AL, CA, CO, FL, GA, IA, IL, KY, LA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI; the District of Columbia and the countries of Belgium, India Italy, Spain, and United Kingdom.
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.