Septodont Recalls Self-Etch Bond Adhesive Due to Packaging Error
Septodont is recalling Self-Etch bond adhesive because the material was incorrectly packaged. The recall involves 60 units distributed to two wholesalers in Pennsylvania and New York.
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 due to incorrect packaging, which is a packaging-only problem with no reported injuries or illnesses, fitting the 'Low' severity criteria.
Plain-English summary
Septodont is recalling Self-Etch bond adhesive because the material was incorrectly packaged. The product, manufactured by Novocol, Inc., is identified as Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive. Each unit contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
The recall covers 60 units with Product Order Number 112-6966, Lot Number C4211-3, and an expiration date of September 2015. The product was distributed to two wholesalers in Pennsylvania and New York. No product was distributed outside of the United States or to government or VA consignees.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
- Manufacturer
- Novocol, Inc.
- Category
- Medical Device — Dental Adhesive
- Hazard
- Affected units
- 60
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 (4)
- Product Order Number 112-6966
- Lot Number C4211-3
- UPC Code *+H65811269662O*
- Expiration Date September 2015.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Novocol, 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.
See all 2 products in this recall →Related recalls
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