The Recall Desk

FDA (Devices) recall action 64272

Ultradent Products, Inc. recalled 2 products on 2013-02-20

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
2013-02-20
Critical
0
Units
132

Why these products were recalled

Incorrect packaging of regular set and fast set cartridges.

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

  • LowFDA (Devices)··2013-02-20

    Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error

    Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.

    Product
    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2013-02-20

    Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error

    Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.

    Product
    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
    Category
    Distribution
    0 states