The Recall Desk

FDA (Devices) recall action 74948

Angiodynamics Inc. (Navilyst Medical Inc.) recalled 2 products on 2016-12-14

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-12-14
Critical
0
Units
—

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-12-14

    Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error

    Angiodynamics Inc. is recalling specific PICC catheters because the stylet diameter may differ from the label, potentially causing stiffening.

    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 Technolo
    Category
    Distribution
    11 states
  • ModerateFDA (Devices)··2016-12-14

    Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error

    Angiodynamics is recalling PICC catheters because the stylet diameter may be larger than stated on the label.

    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 Techn
    Category
    Distribution
    11 states