The Recall Desk

FDA (Devices) recall action 66991

Bard Access Systems recalled 2 products on 2014-01-29

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
2014-01-29
Critical
0
Units
1,558

Why these products were recalled

Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device.

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.

1–2 of 2

  • ModerateFDA (Devices)··2014-01-29

    Bard Access Systems Recalls Low Profile Ports with Undersized Catheters

    Bard Access Systems is recalling Low Profile Ports with 6.6 Fr catheters because some silicone catheters may be undersized to 5.3 Fr.

    Product
    Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-01-29

    Bard Access Systems Recalls MRI Low Profile Ports with Undersized Catheters

    Bard Access Systems is recalling MRI Low Profile Single Lumen ports because some silicone catheters may be undersized to 5.3 Fr instead of the labeled 6.6 Fr.

    Product
    MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort…
    Category
    Distribution
    0 states