Angiodynamics Inc. (Navilyst Medical Inc.): There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.

Agency Publication Date: December 7, 2016

Affected Products

Product: Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; a

Lot #: 4941411

Lot Numbers:

4941411

Product: Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood

Lot #: 4945781

Lot Numbers:

4945781

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74948

Status: Resolved

Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.)

Manufactured In: United States

Units Affected: 2 products (48 cartons (boxes of 5); 50 cartons (boxes of 5))

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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

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Affected Products

Lot #: 4941411

Lot Numbers:

4941411

Lot #: 4945781

Lot Numbers:

4945781