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.
- Company
- Ultradent Products, Inc.
- Recall Initiated
- August 4, 2017
- Terminated
- January 4, 2018
- Recall Number
- Z-3214-2017
- Quantity
- 61 units
- Firm Location
- South Jordan, UT
Reason for Recall
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Distribution
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
Lot / Code Info
Lot numbers BCDZQ, BCPRC, and BD3MT
Root Cause
Process change control
Action Taken
The recalling firm issued letters dated August 4, 2017 via certified mail,2-day delivery mail, or email on August 4, 2017. The letter identified the affected product, problem, and actions to be taken. For questions contact Regulatory Affairs Specialist at Ultradent Products, Inc.
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