The Recall Desk
ModerateFDA (Drugs)·D-0401-2018·Announced 2018-02-21

Sage Q.Care Oral Cleansing System Recalled for Cross-Contamination Risk

Sage Products Inc. is recalling Q.Care Oral Cleansing & 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, and the hazard involves potential 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 60 cases of the Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. The affected product contains one covered Yankauer and Y-Connector, two untreated suction toothbrush packages, two single-dose bottles of 0.12% CHG Oral Rinse, four suction oral swab packages with Perox-A-Mint solution, two suction oral swab packages with alcohol-free mouthwash, and four oropharyngeal suction catheter packages.

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 lots are 52435 (expiration date 10/03/2017) and 57750 (expiration date 09/18/2018), identified by Product Code 6914-S and UPC 6 18029 83017 3.

The 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 and healthcare providers should stop using the affected products and contact Sage Products Inc. for further instructions or a refund.

The recalled product

Product
Q.Care 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 Suction Oral Swab packages with Perox-A-Mint s
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
60

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 (5)

  • Product Code: 6914-S
  • Lots: 52435
  • EXP 10/03/2017
  • 57750
  • EXP 09/18/2018.

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 →

Related recalls

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Same hazard · cross contamination

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