The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0356-2018·Announced 2018-02-21

Sage Products Recalls Oral Cleansing Systems Due to Cross-Contamination Risk

Sage Products Inc. is recalling 2,199 cases of Oral Cleansing & Suctioning System q4 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While no specific injuries are reported in the text, the potential for cross-contamination with non-pharmaceutical products on shared equipment represents a significant health risk warranting a Severe rating under the Class II criteria.

Plain-English summary

Sage Products Inc. is voluntarily recalling 2,199 cases of the Oral Cleansing & Suctioning System q4. The product, identified by Product Code 6504 and UPC 6 18029 83045 6, contains a Covered Yankauer, Suctino Toothbrush packages with Antiplaque solution, Suction Oral Swab packages with Perox-A-Mint solution, and Oropharyngeal Suction Catheter packages. The affected lots are 58174, 59297, 60127, 60673, 61002, 61817, and 61825, with expiration dates ranging from September 2017 to April 2018.

The recall was initiated due to cross-contamination with other products. The oral care solutions included in the system were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products. This shared equipment usage presents a risk of contamination with substances not intended for pharmaceutical use.

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 and healthcare facilities should stop using the affected lots and contact Sage Products Inc. for instructions on returning the product or obtaining a replacement.

The recalled product

Product
Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer, 2 Untreated Suctino Toothbrush packages with Antiplaque solution, 4)Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care Solutions
Hazard
Affected units
2,199

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 (15)

  • Product Code: 6504
  • Lots: 58174
  • EXP 09/11/2017
  • 59297
  • EXP 11/13/2017
  • 60127
  • EXP 01/02/2018
  • 60673
  • EXP 02/05/2018
  • 61002
  • EXP 02/23/2018
  • 61817
  • EXP 03/21/2018
  • 61825
  • EXP 04/27/2018

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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