The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0404-2018·Announced 2018-02-21

Sage Products Recalls Q.Care Oral Cleansing Systems Due to Cross-Contamination

Sage Products Inc 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 source text describes a voluntary precautionary recall due to cross-contamination risk without reporting specific illnesses or injuries, fitting the Moderate severity criteria.

Plain-English summary

Sage Products Inc is voluntarily recalling 16,639 cases of the Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. The product is a kit containing covered Yankauer and Y-Connector, untreated suction toothbrushes, suction oral swabs with Perox-A-Mint solution, and oropharyngeal suction catheters.

The recall was initiated due to cross-contamination with other products. According to the source text, the oral care solutions included in the kits 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.

The affected 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 and healthcare facilities should stop using the product and contact Sage Products Inc for further instructions or a refund. The recall covers specific lot numbers with expiration dates ranging from August 2017 to April 2019.

The recalled product

Product
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2…
Manufacturer
Sage Products Inc
Category
Medical Device — Oral Care / Suctioning
Hazard
Affected units
16,639

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: 6924
  • Lots: 51601
  • EXP 08/15/2017
  • 52138
  • EXP 09/19/2017
  • 52836
  • 52935
  • EXP 11/07/2017
  • 53531
  • EXP 12/12/2017
  • 53788
  • EXP 01/09/2018
  • 54388
  • EXP 02/20/2018
  • 54796
  • 54816
  • EXP 3/13/2018
  • 55130
  • 55171
  • EXP 04/03/2018

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 →

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