Angiodynamics Inc. (Navilyst Medical Inc.) recalls Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are T…

Recall date

June 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0715-2017

FDA classification

Class II

Brand / firm

Angiodynamics Inc. (Navilyst Medical Inc.)

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.