Recall Z-0630-2018 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cook Inc.
Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-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. S
| Date | Jul 31, 2017 |
| Status | Terminated |
| Reason | Central venous catheters may not fit over guide wire potentially causing procedure delay. |
| Root cause | Process control |
| Action | 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 (F |
| Quantity | 85 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.