The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0371-2018·Announced 2018-02-21

Sage Products Recalls Q Care Oral Care Kits Due to Cross-Contamination

Sage Products Inc. is recalling Q Care Continue Care 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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a theoretical cross-contamination risk without reported illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Sage Products Inc. is voluntarily recalling 5,217 cases of Q Care Continue Care for the non-ventilated patient. The product includes a covered Yankauer, suction toothbrush packages, and suction oral swab packages, all containing Corinz Antiseptic Cleansing and 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, creating a risk of cross-contamination. The affected lots have expiration dates ranging from August 2017 to November 2018.

The 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 affected products and contact Sage Products Inc. for further instructions or a refund.

The recalled product

Product
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse, 2 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
5,217

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: 6306
  • Lots: 55203
  • 55207
  • 55505
  • EXP 08/28/2017
  • 56466
  • 56502
  • 56508
  • 56515
  • EXP 09/26/2017
  • 57265
  • EXP 11/13/2017
  • 58129
  • EXP 12/11/2017
  • 59085
  • EXP 6/15/2018
  • 59742
  • EXP 7/16/2018 60163
  • EXP 08/02/2018
  • 60834

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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