The Recall Desk

FDA (Devices) recall action 68794

Novocol, Inc. recalled 2 products on 2014-08-06

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
2014-08-06
Critical
0
Units
84

Why these products were recalled

Septodont is recalling Self-Etch bond because the material was incorrectly packaged.

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

  • LowFDA (Devices)··2014-08-06

    Septodont Recalls Compolite Bond SE Due to Incorrect Packaging

    Septodont is recalling 24 units of Compolite Bond SE dental adhesive because the material was incorrectly packaged. The product was distributed to wholesalers in Pennsylvania and New York.

    Product
    Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
    Category
    Distribution
    2 states
  • LowFDA (Devices)··2014-08-06

    Septodont Recalls Self-Etch Bond Adhesive Due to Packaging Error

    Septodont is recalling Self-Etch bond adhesive because the material was incorrectly packaged. The recall involves 60 units distributed to two wholesalers in Pennsylvania and New York.

    Product
    Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
    Category
    Distribution
    2 states