Peak SE Primer Kits recall: Labeling Error
Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within…
Why was Peak SE Primer Kits recalled?
Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number: B6Z4K.
- 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…
- Recalling firm
- Ultradent Products, Inc.
- Quantity
- 172 kits (4 syringes per kit)
- Distribution
- Worldwide Distribution.
- Recall date
- June 27, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)