FDA (Devices) recall action 73022
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.
Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
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.
Bard Peripheral Vascular Inc is recalling four units of Bard Distaflo Vascular Bypass Grafts due to size mislabeling. The 8 mm grafts are incorrectly labeled as 6 mm.
Bard Peripheral Vascular Inc is recalling four units of the Bard Distaflo Vascular Bypass Graft because the product is mislabeled as 6 mm when it is actually 8 mm.