The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0396-2018·Announced 2018-02-21

Sage Products Recalls Q.CARE Oral Cleansing System 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 involves a voluntary precautionary measure for potential cross-contamination without reported illnesses or injuries, fitting the criteria for a Moderate severity score.

Plain-English summary

Sage Products Inc is voluntarily recalling 5,085 cases of the Q.CARE Oral Cleansing & Suctioning System q4. The product includes a covered Yankauer, suction handle, Y-connector, toothbrush packages with Antiplaque solution, suction oral swab packages with Perox-A-Mint solution, and oropharyngeal suction catheter packages.

The recall was initiated because the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products, creating a risk of cross-contamination. The affected lots are 57567, 58163, 59009, 59637, 60241, 60263, 60631, 61294, and 61321, with expiration dates ranging from August 14, 2017, to March 30, 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 and healthcare facilities should stop using the recalled product and contact Sage Products Inc for further instructions or a refund.

The recalled product

Product
Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Toothbrush packages with Antiplaque solution. 4 Suction Oral Swab packages with Perox-A-Mint solution. 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc.…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care Solutions
Hazard
Affected units
5,085

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 (18)

  • Product Code: 6804
  • Lots: 57567
  • EXP 08/14/2017
  • 58163
  • EXP 09/11/2017
  • 59009
  • EXP 11/03/2017
  • 59637
  • EXP 11/27/2017
  • 60241
  • 60263
  • EXP 01/02/2018
  • 60631
  • EXP 02/05/2018
  • 61294
  • EXP 02/23/2018
  • 61321
  • EXP 03/30/2018.

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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