—#161243

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

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lot Number (Expiration date): 5901462 (30-January-2018)

Why it was recalled

Central venous catheters may not fit over guide wire potentially causing procedure delay.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2017-07-31
Terminated: 2019-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161243. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.