The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0372-2018·Announced 2018-02-21

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

Sage Products 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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Sage Products, Inc. is recalling 2,938 cases of Q Care Continue Care for the non-ventilated patient. The product includes one Covered Yankauer and three Suction Toothbrush packages with 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 shared with non-pharmaceutical products, creating a risk of cross-contamination. The affected lots include 55134, 56144, 56521, 57495, 58716, 59486, 59504, 60426, 61665, 62033, and 62058, with expiration dates ranging from August 2017 to November 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 for a refund or replacement.

The recalled product

Product
Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankauer, 3 Suction Toothbrush packages with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6308 UPC 6 18029 83040 1
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
2,938

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: 6308
  • Lots: 55134
  • EXP 08/28/2017
  • 56144
  • 56521
  • EXP 09/26/2017
  • 57495
  • EXP 11/13/2017
  • 58716
  • EXP 04/03/2018
  • 59486
  • EXP 06/15/2018
  • 59504
  • EXP 07/16/2018
  • 60426
  • EXP 08/02/2018
  • 61665
  • EXP 10/16/2018
  • 62033
  • 62058

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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