The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0394-2018·Announced 2018-02-21

Sage Q.Care Oral System Recalled for Cross-Contamination Risk

Sage Products is recalling Q.Care Oral Cleansing Systems because they were 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 source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination risks.

Plain-English summary

Sage Products Inc. is recalling the Q.Care Petite Size Oral Cleansing & Suctioning System. The recall involves 2,017 cases of the product, which includes components such as suction toothbrushes, antiseptic oral rinse, and suction catheters. The affected lots are 57979, 58845, 60215, and 61235, with expiration dates ranging from September 2017 to March 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 use creates a risk of cross-contamination with other products. The FDA has classified this as a Class II recall.

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 or dispose of the items.

The recalled product

Product
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, and Y-Connector, 2 Petit Size Suction Toothbrushes, 7ml Antiseptic Oral Rinse, Applicator Swab and 2g Mouth Moisturizer, 4 Petit Size Untreated Suction Oral Swabs, 7ml Antiseptic Oral Rinse…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
2,017

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 (9)

  • Product Code: 6714
  • Lots: 57979
  • EXP 09/19/2017
  • 58845
  • EXP 10/09/2017
  • 60215
  • EXP 01/08/2018
  • 61235
  • EXP 03/05/2018.

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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