Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BioFlo PICC with ENDEXO and PASV Recalled by Angiodynamics Inc. (Navilyst Medical Inc.) Due to specific lots of Xcela Power Injectable and BioFlo...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Angiodynamics Inc. (Navilyst Medical Inc.) directly.
Affected Products
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
Quantity: Box of 4 units
Why Was This 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.
Where Was This Sold?
Distributed to accounts in Florida. Foreign distribution to Great Britain.
About Angiodynamics Inc. (Navilyst Medical Inc.)
Angiodynamics Inc. (Navilyst Medical Inc.) has 78 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report