The Recall Desk
ModerateFDA (Drugs)·D-0290-2019·Announced 2018-12-19

CAO Group Recalls fas.TRACT Hemostatic Gel Due to cGMP Violations

CAO Group, Inc. is recalling fas.TRACT Coagulative Hemostatic Gel kits due to current Good Manufacturing Practice (cGMP) violations identified during a recent inspection.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

CAO Group, Inc. is voluntarily recalling 115 kits of fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit. The product is distributed by Benco Dental and is available nationwide in the US. The specific lots affected are # 170831 (expiration date 8/31/2019) and # 180704 (expiration date 7/04/2020).

The recall was initiated because current Good Manufacturing Practice (cGMP) violations were noted during the firm's most recent inspection. The source text does not specify the exact nature of the violations or report any illnesses or injuries associated with the product.

Healthcare professionals and patients who have purchased or used these specific kits should stop using the product and contact the recalling firm or their supplier for instructions on return or disposal.

The recalled product

Product
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
Manufacturer
CAO Group, Inc.
Category
Drug — Dental Hemostatic
Hazard
Affected units
115

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot # 170831
  • EXP 8/31/2019
  • 180704
  • EXP 7/04/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by CAO Group, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · CAO Group, Inc.

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Same hazard · cGMP violation

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