fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
Reported: December 19, 2018 Initiated: November 16, 2018 #D-0290-2019
Product Description
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
Reason for Recall
cGMP violations noted during the firm's most recent inspection.
Details
- Recalling Firm
- CAO Group, Inc.
- Units Affected
- 115 kits
- Distribution
- Nationwide in the US
- Location
- West Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105. Recalled by CAO Group, Inc.. Units affected: 115 kits.
Why was this product recalled? ▼
cGMP violations noted during the firm's most recent inspection.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 19, 2018. Severity: Moderate. Recall number: D-0290-2019.
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