U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
원인
Central venous catheters may not fit over guide wire potentially causing procedure delay.
조치
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.
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.
제품 설명
Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J || 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