FDAFDA · Food and drugs·Recall number Z-0633-2018
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
Published February 21, 2018 · Recall initiated: July 31, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Central venous catheters may not fit over guide wire potentially causing procedure delay.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- 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.
- Lot
- Lot Number (Expiration date): 5901462 (30-January-2018)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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