Reported Dec 19, 2018 · Terminated
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips.…
CAO Group, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CAO Group, Inc. · 4628 W Skyhawk Dr · West Jordan, UT · 84084-4501
Is this the product you have?
- fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips
- Distributed byBenco Dental, 295 Center Point Blvd., Pittston, PA 18640
- NDC14060-01105
- Lot codes and dates
Lot # 170831EXP 8/31/2019180704EXP 7/04/2020
- Amount recalled
- 115 kits
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
cGMP violations noted during the firm's most recent inspection.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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