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..
Reported: October 4, 2017 Initiated: August 4, 2017 #Z-3218-2017
Product Description
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..
Reason for Recall
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Details
- Recalling Firm
- Ultradent Products, Inc.
- Units Affected
- 62 units
- Distribution
- Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
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... Recalled by Ultradent Products, Inc.. Units affected: 62 units.
Why was this product recalled? ▼
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 4, 2017. Severity: Moderate. Recall number: Z-3218-2017.
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