Recall Z-1146-2018
Vascular Insights, LLC · initiated November 9, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot number: BM651403017I
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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 product and provide directions to follow the instructions contained herein. Customers were asked to complete and return the enclosed Reply Verification Tracking Form.
Details
- Recall number
- Z-1146-2018
- Initiated
- November 9, 2017
- Terminated
- December 18, 2018
- Product code
- KRA – Catheter, Continuous Flush
- 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
- Recalling firm
- Vascular Insights, LLC, Quincy, MA