Angiodynamics Inc. (Navilyst Medical Inc.): 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.; specific lots of Xcela Power Injectable and BioFlo PICCs are

Agency Publication Date: December 11, 2018

Affected Products

Product: Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711

Lot 5096448

Lot Numbers:

5096448

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

5231609

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81477

Status: Resolved

Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)

Manufactured In: United States

Units Affected: 2 products (Box of 1 Units; Box of 4 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Medium RiskFDA Device