Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F Recalled by Navilyst Medical, Inc., an AngioDyamics Company Due to PICC catheters that contain valve(s) manufactured prior to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Navilyst Medical, Inc., an AngioDyamics Company directly.
Affected Products
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
Quantity: 328 units
Why Was This Recalled?
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Navilyst Medical, Inc., an AngioDyamics Company
Navilyst Medical, Inc., an AngioDyamics Company has 23 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report