The Recall Desk
ModerateFDA (Drugs)·D-0352-2018·Announced 2018-02-21

Sage QCare Rx Oral Cleansing System Recalled for Cross-Contamination

Sage Products Inc. is recalling QCare Rx Oral Cleansing and Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any specific illnesses, injuries, or fatalities, and the hazard is described as cross-contamination without specific pathogen identification, fitting the criteria for a moderate severity score.

Plain-English summary

Sage Products Inc. is recalling 48,003 cases of the QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) 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 contains a Covered Yankauer and Y-Connector, untreated suction toothbrushes, single-dose bottles of 0.12% CHG Oral Rinse, suction oral swabs with Perox-A-Mint Solution or Alcohol-Free Mouthwash, and oropharyngeal suction catheters. The recall covers specific lot numbers with expiration dates ranging from August 2017 to December 2018.

The product 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 Sage Products Inc. for instructions on return or disposal.

The recalled product

Product
QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q2. Contains: 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages with Perox-A-M
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
48,003

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: 6912
  • Lots: 52736
  • 52807
  • 52878
  • 52994
  • 53067
  • 53084
  • 53137
  • 53192
  • EXP 08/31/2017
  • 53363
  • 53459
  • 53695
  • 53748
  • 53868
  • EXP 9/30/2017
  • 53916
  • 54003
  • 54011
  • 54012

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 →

Related recalls

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Same hazard · cross contamination

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