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

Recall date

October 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0596-2019

FDA classification

Class II

Brand / firm

Angiodynamics Inc. (Navilyst Medical Inc.)

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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