Navilyst Medical, Inc., an AngioDyamics Company: Medical Device Recall in 2016 - (Recall #: Z-1969-2016)

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 MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, 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.

Product Classification:

Class II

Date Initiated: March 14, 2016

Date Posted: June 22, 2016

Recall Number: Z-1969-2016

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: 1,786 units

Code Information:

Batch/Lots: 1) 4724924, 4724925 & 4730412 with Use By 2016-03-31. Batch/Lots: 2) 4724929, 4724923, 4725426, 4730400 & 4753766 with Use By Range 2016-03-31 to 2016-07-31. Batch/Lots: 3) 4724927 Use By 2016-03-31.

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