[Recalled] 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. — T
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Ultradent Products, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-3216-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 04 August 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Ultradent Products, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.