Recall Z-0715-2017— Angiodynamics Inc. (Navilyst Medical Inc.)

Name: FDA recall Z-0715-2017
Creator: U.S. Food and Drug Administration
Published: 2016-06-08

Class II · Terminated

Class II FDA medical device recall by Angiodynamics Inc. (Navilyst Medical Inc.), initiated 2016-06-08, terminated 2018-06-15. It names one FDA 510(k) clearance: K142616. 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; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.. Reason: 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..

Recalling firm: Angiodynamics Inc. (Navilyst Medical Inc.)
Classification: Class II
Status: Terminated
Initiated: 2016-06-08
Terminated: 2018-06-15
Firm location: Glens Falls, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K142616 — PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.·cleared 2014-10-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.