FDA-Device2018-12-19Class II
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
Angiodynamics Inc. (Navilyst Medical Inc.)
Hazard
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.
Sold states
Distributed to accounts in Florida. Foreign distribution to Great Britain.
Affected count
Box of 4 units
Manufactured in
10 Glens Falls Tech Park, N/A, Glens Falls, NY, United States
Products
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0596-2019Don't want to check this manually?
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