Device product
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.
Z-1146-2018
Product summary
- Event
- Event 79324
- Status
- Terminated
- Classification
- Class II
- Quantity
- 928
- Official record key
device-enforcement:Z-1146-2018
Official wording
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.
Code information: Lot number: BM651403017I
Distribution pattern: 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
Derived failure modes
-
Manufacturing or process control
manufacturing defect