Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error
Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging error without reported injuries or illnesses.
Plain-English summary
Ultradent Products, Inc. is recalling 100 cartridges of Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3. The product is used in prosthodontics and was distributed nationwide.
The recall was initiated because of incorrect packaging of regular set and fast set cartridges. This packaging error could lead to the use of the wrong material type during dental procedures.
Dental professionals and patients who have used or possess this specific lot number should stop using the product and contact Ultradent Products for further instructions.
The recalled product
- 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.
- Manufacturer
- Ultradent Products, Inc.
- Hazard
- Affected units
- 100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. B7DS3
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ultradent Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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