Angiodynamics Inc. (Navilyst Medical Inc.): Medical Device Recall in 2018 - (Recall #: Z-0596-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481

Product Classification:

Class II

Date Initiated: October 16, 2018

Date Posted: December 19, 2018

Recall Number: Z-0596-2019

Event ID: 81477

Reason for Recall:

specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.

Status: Terminated

Product Quantity: Box of 4 units

Code Information:

5231609

Distribution Pattern:

Distributed to accounts in Florida. Foreign distribution to Great Britain.

Voluntary or Mandated:

Voluntary: Firm initiated