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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 3 Recall
Chromaclone PVS Heavy (Fast Set)		see related information
Date Posted February 13, 2013
Recall Number Z-0812-2013
Product Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
Code Information Lot No. B7DS3
Recalling Firm/
Manufacturer		 Ultradent Products, Inc.
505 W 10200 S
South Jordan, Utah 84095-3935
Consumer Instructions No consumer action necessary
For Additional Information Contact Corey Jaseph
801-553-4420
Reason for
Recall		 Incorrect packaging of regular set and fast set cartridges.
Action 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.
Quantity in Commerce 100 cartridges
Distribution Nationwide Distribution
 
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