Recall Z-0632-2018— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2017-07-31, terminated 2019-05-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH 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. Reason: Central venous catheters may not fit over guide wire potentially causing procedure delay..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-31
- Terminated
- 2019-05-08
- Firm location
- Bloomington, IN, United States
Product description
Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH 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
Reason for recall
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Data sourced from openFDA. This site is unofficial and independent of the FDA.