The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0373-2018·Announced 2018-02-21

Sage Products Recalls Q CARE Oral Cleaning System Due to Cross-Contamination

Sage Products is recalling Q CARE q4 Oral Cleaning & 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, which typically corresponds to a moderate severity level involving temporary or medically reversible health consequences, without reports of serious injury or death.

Plain-English summary

Sage Products, Inc. is recalling 2,194 cases of the Q CARE q4 Oral Cleaning & Suctioning System. The product contains a covered Yankauer, Y-Connector, suction toothbrushes with Antiplaque solution, and suction oral swabs with Antiseptic Oral Rinse. The recall affects specific lots with expiration dates ranging from October 2017 to February 2018.

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 products were 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 recalled products and contact Sage Products, Inc. for instructions on how to return or dispose of the items. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Q CARE q4 Oral Cleaning & 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. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6404…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
2,194

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 (13)

  • Product Code: 6404
  • Lots: 58394
  • EXP 10/02/2017
  • 59185
  • EXP 11/03/2017
  • 59782
  • EXP 11/27/2017
  • 59799
  • EXP 01/02/2018
  • 60776
  • EXP 01/22/2018
  • 61185
  • EXP 02/23/2018.

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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