Z-3214-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 4, 2017
- Initiation Date
- August 4, 2017
- Termination Date
- January 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 units
Product Description
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.
Reason for Recall
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Distribution Pattern
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
Code Information
Lot numbers BCDZQ, BCPRC, and BD3MT