Device 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
Z-0633-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79050
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50
- Official record key
device-enforcement:Z-0633-2018
Official wording
Reason: Central venous catheters may not fit over guide wire potentially causing procedure delay.
Code information: Lot Number (Expiration date): 5901462 (30-January-2018)
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.
Derived failure modes
-
Unknown
Central venous catheters may not fit over guide wire potentially causing procedure delay.