Recall Z-1967-2016— Navilyst Medical, Inc., an AngioDyamics Company

Name: FDA recall Z-1967-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-14

Class II · Terminated

Class II FDA medical device recall by Navilyst Medical, Inc., an AngioDyamics Company, initiated 2016-03-14, terminated 2018-06-11. It names one FDA 510(k) clearance: K021704. Product: 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.. Reason: 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..

Recalling firm: Navilyst Medical, Inc., an AngioDyamics Company
Classification: Class II
Status: Terminated
Initiated: 2016-03-14
Terminated: 2018-06-11
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K021704 — VAXCEL PICC WITH PASV VALVE TECHNOLOGYCatheter Innovations, Inc.·cleared 2002-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.