FDAFDA · Food and drugs·Recall number Z-0741-2018
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Published March 7, 2018 · Recall initiated: September 28, 2017
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
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cosmedent, Inc.
- Distributor
- Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.
- Lot
- SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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