Navilyst Medical, Inc., an AngioDyamics Company: Medical Device Recall in 2016 - (Recall #: Z-1966-2016)

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 Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, 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-1966-2016

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: 2,716 units

Code Information:

Batch/Lots: 1) 4732402, 4745359, 4824107, 4827333, 4835750, 4860987 & 48698433, 2) 4772713, 4786763, 4790018, 4817452 & 3) 4725793, 4745367, 4748673, 4756297, 4765394, 4773295, 4784468, 4788536 & 4845665 with Use By 2016-04-30.

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