Z-1146-2018 Class II Terminated
FDA device recall Z-1146-2018 was initiated by Vascular Insights, LLC on November 9, 2017 and is designated Class II. 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… The recall status is terminated (terminated December 18, 2018). Affected quantity: 928.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- November 9, 2017
- Termination Date
- December 18, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 928
Product Description
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.
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.
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
Code Information
Lot number: BM651403017I