The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0374-2018·Announced 2018-02-21

Sage Q CARE Oral Cleansing System Recalled for Cross-Contamination

Sage Products is recalling Q CARE q2 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 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 6,200 cases of the Q CARE q2 Oral Cleansing & Suctioning System. The product contains a covered Yankauer, Y-connector, suction toothbrushes, oral swabs, and oropharyngeal suction catheters. The recall is due to cross-contamination, as the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products.

The affected lots are 58432, 59402, 59864, 60799, 61115, and 61557, with expiration dates ranging from October 2017 to March 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 should stop using the product and contact Sage Products Inc. for further instructions or a refund.

The recalled product

Product
Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 6 Suction Oral Swab packages with Alcohol-Free mouthwash, 4…
Manufacturer
Sage Products Inc
Category
Medical Device — Oral Care
Hazard
Affected units
6,200

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 (12)

  • Product Code: 6412
  • Lots: 58432
  • EXP 10/02/2017
  • 59402
  • EXP 11/13/2017
  • 59864
  • EXP 01/02/2018
  • 60799
  • EXP 01/22/2018
  • 61115 EXP 02/23/2018
  • 61557
  • 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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