The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0398-2018·Announced 2018-02-21

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

Sage Products Inc. is recalling Q.Care Oral Cleansing & 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 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving potential contamination or significant injury risks, even if specific hospitalizations are not explicitly detailed in the provided text snippet.

Plain-English summary

Sage Products Inc. is voluntarily recalling 6,130 cases of the Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. The recall is due to cross-contamination, as the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products.

The affected product, Product Code 6904, was distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Specific lot numbers and expiration dates are listed in the recall notice, ranging from August 2017 to December 2018.

Consumers and healthcare facilities should stop using the affected product and contact Sage Products Inc. for further instructions or a refund. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Suction Handle, Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab packages…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care / Rinse
Hazard
Affected units
6,130

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: 6904
  • Lots: 52850
  • 53281
  • EXP 08/31/2017
  • 53300
  • 53579
  • EXP 09/30/2017
  • 54320
  • EXP 10/31/2017
  • 54960
  • EXP 11/30/2017
  • 55753
  • EXP 12/31/2017
  • 56914
  • EXP 02/28/2018
  • 57352
  • EXP 04/30/2018
  • 57836
  • EXP 03/31/2018
  • 58349

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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