The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0387-2018·Announced 2018-02-21

Sage Products Recalls Oral Care Systems Due to Cross-Contamination

Sage Products Inc. is recalling Oral Cleansing & Suctioning Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

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, and the hazard is a theoretical risk of cross-contamination with non-pharmaceutical products without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Sage Products Inc. is recalling 5,138 cases of its Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. The recall was initiated because the oral care solutions were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products, creating a risk of cross-contamination.

The affected product, Product Code 6594, includes components such as covered Yankauer and Y-Connectors, untreated suction toothbrushes, single-dose bottles of 0.12% CHG Oral Rinse, suction oral swabs with sodium bicarbonate, Perox-A-Mint solution, mouth moisturizer, and oropharyngeal suction catheters. The recall covers specific lots with expiration dates ranging from August 2017 to December 2018.

The product was distributed nationwide in the United States and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Consumers and healthcare facilities should stop using the affected product and contact Sage Products Inc. for further instructions or a refund.

The recalled product

Product
Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4, Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Packages Suction Oral Swab with sodium bicarbonate…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
5,138

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 (20)

  • Product Code: 6594
  • Lots: 53018
  • 53824
  • EXP 08/08/2017
  • 53023
  • EXP 08/31/2017
  • 53833
  • EXP 09/30/2017
  • 53949
  • EXP 10/03/2017
  • 54045
  • EXP 10/31/2017
  • 55087
  • 55169
  • EXP 11/30/2017
  • 54708
  • 55699
  • 55730
  • 55952
  • 56028

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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