The Recall Desk

FDA (Devices) recall action 67149

Davol, Inc., Subs. C. R. Bard, Inc. 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
65

Why these products were recalled

Product labeling does not match product configuration.

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

1–2 of 2

  • ModerateFDA (Devices)··2014-01-29

    FDA Recalls Composix L/P Mesh Due to Labeling Mismatch

    Davol, Inc. is recalling 46 units of Composix L/P Mesh with Echo PS Positioning System because the product labeling does not match the product configuration.

    Product
    Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction…
    Category
    Distribution
    14 states
  • ModerateFDA (Devices)··2014-01-29

    FDA Recalls Composix L/P Mesh Due to Labeling Mismatch

    Davol, Inc. is recalling 19 units of Composix L/P Mesh with Echo PS Positioning System because the product labeling does not match the product configuration.

    Product
    Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the…
    Category
    Distribution
    14 states