The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0354-2018·Announced 2018-02-21

Sage Products Recalls QCare RX Oral Cleansing System Due to Cross-Contamination

Sage Products is recalling 9,006 cases of QCare RX Oral Cleansing Systems because they 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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is theoretical cross-contamination without reported illnesses.

Plain-English summary

Sage Products Inc. is recalling 9,006 cases of the QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) 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, creating a risk of cross-contamination.

The affected product includes a covered Yankauer and Y-Connector, untreated suction toothbrushes, single-dose bottles of 0.12% CHG Oral Rinse, suction oral swabs, and oropharyngeal suction catheters. The recall covers specific lot numbers with expiration dates ranging from August 2017 to October 2018.

The product was distributed nationwide in the United States and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Consumers and healthcare providers should stop using the product and contact Sage Products Inc. for further instructions or a refund.

The recalled product

Product
QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse Corinz. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 10 Suction Oral Swab packages with…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
9,006

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: 6962
  • Lots: 55604
  • 55619
  • 56000
  • 56052 EXP 08/28/2017
  • 56211
  • 56282
  • 56783
  • EXP 09/26/2017
  • 57204
  • 57614
  • 58027
  • EXP 11/13/2017
  • 58549
  • 58587
  • EXP 04/03/2018
  • 59493
  • EXP 07/16/2018
  • 60043
  • 60079

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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