Recall Z-1146-2018 ยท KRA Catheter, Continuous Flush
Vascular Insights, LLC
ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.
| Date | Nov 9, 2017 |
| Status | Terminated |
| Reason | Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer. |
| Root cause | Process control |
| Action | Vascular Insights sent an Urgent Voluntary Medical Device Recall letter to their customers. The letter identified the affected product, problem and the actions to be taken. Customers were instructed to 1. Do not use or distribute any recalled product. 2. Immediately remove all recalled product from your inventory. 3. Segregate recalled product in a secure location and follow the instruction herein to return the recalled product and receive replacement product. 4. Immediately forward a copy of this recall notification to any/all sites to which you may have distributed the affected prod |
| Quantity | 928 |
| Distribution | U.S Nationwide in the states: AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MO, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071468 | CLARIVEIN CATHETER Vascular Insights, LLC, Mar 20, 2008 |