The Recall Desk

FDA (Devices) recall action 77891

Ultradent Products, Inc. recalled 5 products on 2017-10-04

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2017-10-04
Critical
0
Units
454

Why these products were recalled

The barcode label was placed underneath the sterile barrier and the product was re-wrapped.

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.

1–5 of 5

  • ModerateFDA (Devices)··2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.

    Product
    Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.

    Product
    Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-10-04

    Ultradent Paper Points Recalled for Sterile Barrier Labeling Error

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterile status.

    Product
    Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterility.

    Product
    Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-10-04

    Ultradent Paper Points Recalled Due to Sterile Barrier Label Placement

    Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, potentially compromising sterility.

    Product
    Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
    Category
    Distribution
    0 states