The Recall Desk

FDA (Devices) recall action 87656

Bard Peripheral Vascular Inc recalled 3 products on 2021-05-19

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2021-05-19
Critical
0
Units
2,670

Why these products were recalled

Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.

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.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2021-05-19

    Bard PowerPort duo MRI Implantable Port Recalled for Catheter Function Issues

    Bard Peripheral Vascular Inc is recalling 189 units of PowerPort duo MRI Implantable Ports due to potential catheter flushing difficulties and septum dislodgement.

    Product
    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood produc
    Category
    Distribution
    40 states
  • HighFDA (Devices)··2021-05-19

    Bard PowerPort duo M.R.I. Implantable Port Recall for Catheter Issues

    Bard Peripheral Vascular Inc. is recalling 287 PowerPort duo M.R.I. Implantable Ports due to catheter flushing difficulties and septum dislodgement.

    Product
    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood product
    Category
    Distribution
    40 states
  • HighFDA (Devices)··2021-05-19

    Bard PowerPort duo MRI Implantable Port Recalled for Catheter Function Issues

    Bard Peripheral Vascular Inc. is recalling 2,194 PowerPort duo M.R.I. Implantable Ports due to potential catheter flushing, infusion, and aspiration difficulties, as well as septum dislodgement.

    Product
    PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood produc
    Category
    Distribution
    40 states