Recall Z-3216-2017— Ultradent Products, Inc.
Class II · Terminated
Class II FDA medical device recall by Ultradent Products, Inc., initiated 2017-08-04, terminated 2018-01-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The barcode label was placed underneath the sterile barrier and the product was re-wrapped..
- Recalling firm
- Ultradent Products, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-08-04
- Terminated
- 2018-01-04
- Firm location
- South Jordan, UT, United States
Product description
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.
Reason for recall
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Data sourced from openFDA. This site is unofficial and independent of the FDA.