Sage Products Recalls Nose to Toes Skin Antisepsis System Due to Cross-Contamination
Sage Products Inc. is recalling the Nose to Toes Skin Antisepsis System because oral care components were manufactured on equipment shared with non-pharmaceutical products.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which is typically associated with a temporary or medically reversible adverse health consequence. The source text does not report any illnesses, injuries, or fatalities, and the hazard is a theoretical cross-contamination risk rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Sage Products Inc. is recalling the Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. The product includes 2% Chlorhexidine Gluconate Cloth, Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, an Ultra-Soft Toothbrush, an Applicator Swab treated with Sodium Bicarbonate, and 3M Skin and Nasal Antiseptic (Povidone-Iodine Solution 5%w/w). The recall is limited to Product Code 9010, Lots 60298 and 60352, with an expiration date of 04/01/2018.
The recall was initiated due to cross-contamination with other products. Specifically, the oral care solutions included in the system were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products. This shared equipment usage presents a risk of contamination that is not appropriate for pharmaceutical-grade oral care items.
The affected products were distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Consumers who have this product should stop using it and contact Sage Products Inc. for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. 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…
- Manufacturer
- Sage Products Inc
- Category
- Drug — Antiseptic / Oral Care
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)
- Product Code: 9010
- Lots: 60298
- 60352
- EXP 04/01/2018
Distribution
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.
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