Device product
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
Z-0811-2013
Product summary
- Event
- Event 64272
- Status
- Terminated
- Classification
- Class III
- Quantity
- 32 cartridges
- Official record key
device-enforcement:Z-0811-2013
Official wording
Reason: Incorrect packaging of regular set and fast set cartridges.
Code information: Part No. 5012, Lot No. B7PPC
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Labeling or packaging
Incorrect packaging