The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0399-2018·Announced 2018-02-21

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

Sage Products is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions 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, and the hazard involves cross-contamination from shared equipment with non-pharmaceutical products. No specific illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.

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. The affected product includes components such as covered Yankauer suction tips, suction toothbrushes, and single-dose bottles of oral rinse. The recall is limited to specific lots: 54675 (expiration date 03/06/2018) and 60933 (expiration date 03/12/2019).

The recall was initiated due to cross-contamination with other products. The oral care solutions were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products. This shared equipment usage creates a risk of contamination that does not meet pharmaceutical standards.

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 and healthcare facilities should stop using the affected lots 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 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-Mint…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care / Pharmaceutical
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: 6912-S
  • Lots: 54675
  • EXP 03/06/2018
  • 60933
  • EXP 03/12/2019.

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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