The Recall Desk

FDA (Devices) recall action 85631

Angiodynamics, Inc. recalled 4 products on 2020-06-24

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2020-06-24
Critical
0
Units
478,892

Why these products were recalled

Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Devices)··2020-06-24

    AngioDynamics PICC Kits Recalled Due to Defective Saline Flush Syringes

    AngioDynamics is recalling certain PICC Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.

    Product
    BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H96560M0125711 H96560M0133541 H96560M0354721…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-06-24

    AngioDynamics Recalls PICC Kits Containing Recalled BD Saline Flush Syringes

    AngioDynamics is recalling BioFlo and Xcela PICC kits because they contain BD saline flush syringes that were previously recalled by BD Medical.

    Product
    BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: 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 and nutrients; the…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-06-24

    AngioDynamics PICC Kits Recalled Due to Defective BD Saline Flush Syringes

    AngioDynamics is recalling BioFlo and Xcela PICC Convenience Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.

    Product
    BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: 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 and nutrients; the sampling of blood…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2020-06-24

    AngioDynamics Recalls PICC Kits Containing Recalled BD Syringes

    AngioDynamics is recalling certain PICC Kits because they contain BD PosiFlush SF Saline Flush Syringes that were previously recalled by BD Medical.

    Product
    BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H965460151 H965460161…
    Category
    Distribution
    0 states