The Recall Desk
ModerateFDA (Drugs)·D-0410-2018·Announced 2018-02-21

Sage Products Recalls Chlorhexidine Skin and Oral Care Kits

Sage Products Inc. is recalling 150 cases of skin antisepsis and oral cleansing kits due to cross-contamination risks from shared manufacturing equipment.

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

Sage Products Inc. is recalling 150 cases of a product containing 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. The recall is due to cross-contamination with other products, as the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products.

The affected product, identified by Product Code 9009 and Lot 60354 with an expiration date of 04/01/2018, was distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand.

Consumers should stop using the product and contact the manufacturer for further instructions or a refund.

The recalled product

Product
Skin antisepsis and oral cleansing. Contains Three 2-packs of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation and One 7ml Burst Pouch of Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, I Ultra-Soft Toothbrush, 1 Applicator Swab treated with Sodium
Manufacturer
Sage Products Inc
Category
Drug — Antiseptic / Oral Care
Hazard
Affected units
150

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 (3)

  • Product Code: 9009
  • Lots: 60354
  • EXP 04/01/2018.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 64 recalled by Sage Products 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 64 products in this recall →

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