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.
FDA Recall Z-1146-2018 · Posted None
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Recalling FirmVascular Insights, LLC
Recall StatusTerminated
Product CodeKRA
Date Initiated2017-11-09
Date Terminated2018-12-18
Product Quantity928
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.
Firm 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 product and provide directions to follow the instructions contained herein.
Customers were asked to complete and return the enclosed Reply Verification Tracking Form.
Root Cause
Process control
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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