Navilyst Medical, Inc., an AngioDyamics Company: Medical Device Recall in 2016 - (Recall #: Z-1972-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 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.

Product Classification:

Class II

Date Initiated: March 14, 2016

Date Posted: June 22, 2016

Recall Number: Z-1972-2016

Event ID: 73598

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.

Status: Terminated

Product Quantity: 1,127 units

Code Information:

Batch/Lots: 1) 4738829, 2) 4732404, 4749417, 4774464, 4793677, 4819468, 4829479, 3) 4725435, 4745700, 4755306, 4764067, 4801103 & 4827331 with Use By Date 2016-04-30 to 2016-10-31.

Distribution Pattern:

Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.

Voluntary or Mandated:

Voluntary: Firm initiated