FDAFDA · Food and drugs·Recall number Z-2128-2014
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.
Published August 6, 2014 · Recall initiated: July 16, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Novocol, Inc.
- Distributor
- Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
- Lot
- Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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