The Recall Desk

FDA (Devices) recall action 63069

Davol, Inc., Subs. C. R. Bard, Inc. recalled 2 products on 2012-09-26

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
2012-09-26
Critical
0
Units
98

Why these products were recalled

Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh

Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh product

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)··2012-09-26

    FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products

    Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to packaging mislabeling where product sizes do not match package labels.

    Product
    Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-09-26

    FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products

    Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to size mislabeling on the packaging.

    Product
    Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use…
    Category
    Distribution
    0 states