The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0349-2018·Announced 2018-02-21

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

Sage Products is recalling Q Care Oral Cleansing & Suctioning System kits 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 a theoretical risk of cross-contamination from shared equipment without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Sage Products Inc. is recalling the Q Care, Oral Cleansing & Suctioning System Corinz. The product includes a covered Yankauer and Y-Connector, suction toothbrush packages, suction oral swab packages, and oropharyngeal suction catheter packages, all containing Corinz Antiseptic Cleansing & Moisturizing Oral Rinse.

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. This shared equipment use creates a risk of cross-contamination with other products.

The affected lots are 55152, 57055, 57078, 58213, 58255, 59031, 59036, 59087, 59781, and 59803. 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 for a refund or replacement.

The recalled product

Product
Q Care, Oral Cleansing & Suctioning System Corinz. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing & Moisturizing Oral Rinse, 2…
Manufacturer
Sage Products Inc
Category
Medical Device — Oral Care
Hazard

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: 6462
  • Lots: 55152
  • EXP 08/28/2017
  • 57055
  • EXP 09/26/2017
  • 57078
  • EXP 11/13/2017
  • 58213
  • EXP 12/22/2017
  • 58255
  • EXP 04/02/2018
  • 59031
  • EXP 04/03/2018
  • 59036
  • 59087
  • EXP 06/15/2018
  • 59781
  • EXP 07/30/2018
  • 59803
  • EXP 07/16/2018.

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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