The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0389-2018·Announced 2018-02-21

Sage Products Recalls Toothette Oral Care Systems Due to Cross-Contamination

Sage Products Inc. is recalling Toothette Oral Care Q Care & 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 potential 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 2,408 cases of the Toothette Oral Care Q Care & Suctioning System. The product contains a Covered Yankauer, Suction Handle and Y-Connector, Suction Toothbrush packages with Perox-A-Mint solution, Suction Oral Swab packages with Perox-A-Mint solution, and Oropharyngeal Suction Catheter packages.

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 have expiration dates ranging from September 12, 2017, to April 9, 2019.

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 instructions on how to return it.

The recalled product

Product
Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Suction Toothbrush packages with Perox-A-Mint solution, 10 Suction Oral Swab packages with Perox-A-Mint solution, 4 Oropharyngeal Suction Catheter packages. Sage…
Manufacturer
Sage Products Inc
Category
Medical Device — Oral Care
Hazard
Affected units
2,408

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: 6602
  • Lots: 52005
  • EXP 09/12/2017
  • 52917
  • EXP 11/07/2017
  • 53327
  • EXP 12/05/2017
  • 54186
  • EXP 02/06/2018
  • 55327
  • EXP 04/17/2018
  • 56169
  • EXP 06/12/2018
  • 57385
  • EXP 08/29/2018
  • 58564
  • EXP 10/30/2018
  • 60205
  • EXP 11/27/2018
  • 61033

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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