Angiodynamics Inc. (Navilyst Medical Inc.): Medical Device Recall in 2016 - (Recall #: Z-0715-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

Product Classification:

Class II

Date Initiated: June 8, 2016

Date Posted: December 14, 2016

Recall Number: Z-0715-2017

Event ID: 74948

Reason for Recall:

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.

Status: Terminated

Product Quantity: 50 cartons (boxes of 5)

Code Information:

Lot #: 4945781

Distribution Pattern:

Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX

Voluntary or Mandated:

Voluntary: Firm initiated