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Recall Observatory FDA recall evidence

Device product

Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

Z-0741-2018

September 28, 2017

Class II

Product summary

Firm
Cosmedent, Inc.
Event
Event 78479
Status
Terminated
Classification
Class II
Quantity
84 units
Official record key
device-enforcement:Z-0741-2018

Official wording

Reason: Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.

Code information: SKU #663-103, Lot No. 164222A, Exp. Date 10/31/2019

Distribution pattern: Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.