Ultradent Recalls Peak SE Primer Kits Due to Mislabeled Syringes
Ultradent is recalling specific Peak SE Primer Kits because a syringe was mislabeled as Peak LC Bond Resin, posing a risk to dental bonding procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ultradent Products, Inc. is recalling 172 kits of Peak SE Primer (Lot B6Z4K) due to a field complaint received on May 10, 2012. The complaint reported that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. The affected product is a self-etch primer used by dental professionals for bonding needs in restorative dental procedures.
The product is contained in prefilled, labeled syringes within a transparent plastic container. The recall is limited to Lot B6Z4K, which was distributed worldwide. The mislabeling could lead to the use of the incorrect dental material during procedures.
Dental professionals should check their inventory for Peak SE Primer Kits with Lot number B6Z4K. If found, these kits should be removed from use and returned to Ultradent Products, Inc. according to the company's instructions.
The recalled product
- Product
- Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with…
- Manufacturer
- Ultradent Products, Inc.
- Hazard
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 number: B6Z4K.
Distribution
Distribution scope not specified by the agency.
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