The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0408-2018·Announced 2018-02-21

Sage Products Recalls Oral Care System Due to Cross Contamination

Sage Products Inc. is recalling the Q Care Oral Cleansing & Suctioning System because it was manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly when involving potential contamination or significant injury risks, even if specific hospitalization reports are not detailed in the provided text snippet.

Plain-English summary

Sage Products Inc. is recalling the Q Care Oral Cleansing & Suctioning System, which is compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. The recall involves 1,273 cases of the product, which includes components such as covered Yankauer suction tips, suction toothbrushes, and oral swabs. The affected lots are 58092, 60090, 60663, 61261, and 61947, with expiration dates ranging from December 2017 to November 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. This shared equipment usage created a risk of cross-contamination with other products. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The product was distributed nationwide in the United States and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Consumers and healthcare providers should stop using the recalled product and contact Sage Products Inc. for further instructions or a refund.

The recalled product

Product
Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 4 Suction Oral Swab packages with Corinz Antiseptic Cleansing and Moisturizing Oral…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
1,273

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 (11)

  • Product Code: 6994
  • Lots: 58092
  • EXP 12/11/2017
  • 60090
  • EXP 07/30/2018
  • 60663
  • EXP 09/06/2018
  • 61261
  • EXP 09/11/2018
  • 61947
  • EXP 11/12/2018

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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