Angiodynamics Inc. (Navilyst Medical Inc.): Medical Device Recall in 2019 - (Recall #: Z-0501-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

Product Classification:

Class II

Date Initiated: September 18, 2019

Date Posted: November 27, 2019

Recall Number: Z-0501-2020

Event ID: 83907

Reason for Recall:

Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.

Status: Terminated

Product Quantity: 582

Code Information:

5487932, 5487933, 5488008

Distribution Pattern:

Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated