medical Class II Updated 2018-12-19

Angiodynamics Inc. (Navilyst Medical Inc.) recalls BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - M

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Distributed to accounts in Florida. Foreign distribution to Great Britain.
Lot/Code Info: 5231609
View official government recall

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