Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
- Company
- Ultradent Products, Inc.
- Recall Initiated
- February 4, 2013
- Posted
- February 13, 2013
- Terminated
- May 30, 2013
- Recall Number
- Z-0812-2013
- Quantity
- 100 cartridges
- Firm Location
- South Jordan, UT
Reason for Recall
Incorrect packaging of regular set and fast set cartridges.
Distribution
Nationwide Distribution
Lot / Code Info
Lot No. B7DS3
Root Cause
Packaging process control
Action Taken
Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected products. They may continue to use product or dispose unwanted cartridges and reply back to firm indicating acknowledgement of letter and if replacement is needed. Consumers with questions can call the firm at 801-553-4420. For questions regarding this recall call 801-553-4420.
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