The Recall Desk

FDA (Devices) recall action 64425

Bard Access Systems recalled 2 products on 2013-03-13

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
2013-03-13
Critical
0
Units
268

Why these products were recalled

Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.

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)··2013-03-13

    Bard Access Systems Recalls Dual Lumen Catheters Due to Wrong Introducer Size

    Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.

    Product
    Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequat
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-03-13

    Bard Access Systems Recalls Hickman and Leonard Catheters Due to Wrong Introducer Size

    Bard Access Systems is recalling specific lots of Hickman and Leonard catheters because the kits included the wrong size introducer.

    Product
    Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and fo
    Category
    Distribution
    0 states