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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 identified as a packaging error without reported injuries.
Plain-English summary
Ultradent Products, Inc. is recalling 32 cartridges of Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material. The specific product affected is Part No. 5012, Lot No. B7PPC. This product is used in prosthodontics.
The recall was initiated because of incorrect packaging of regular set and fast set cartridges. The source text does not specify the nature of the packaging error or any associated health risks.
The product was distributed nationwide. The source text does not provide instructions for consumers or healthcare providers on how to handle the recalled product.
The recalled product
- 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.
- Manufacturer
- Ultradent Products, Inc.
- Hazard
- Affected units
- 32
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 (2)
- Part No. 5012
- Lot No. B7PPC
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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