The Recall Desk
SevereFDA (Drugs)·D-0405-2018·Announced 2018-02-21

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

Sage Products Inc. is recalling Q.Care Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a 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 hospitalization reports are not detailed in the provided text snippet.

Plain-English summary

Sage Products Inc. is recalling 3,928 cases of the Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. The product includes components such as a covered Yankauer, suction toothbrush, single-dose bottles of 0.12% CHG Oral Rinse, and suction oral swabs. The recall is due to cross-contamination with other products, as the oral care solutions were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products.

The affected product 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 documentation, including lots 56718, 57387, 57414, 57423, 58272, 59592, 60142, 60541, 60767, 61159, 61467, and 62075.

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

The recalled product

Product
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse q4. Contains 1 Covered Yankauer and Y-Connector, 1 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Suction Oral Swab pack
Manufacturer
Sage Products Inc
Category
Drug — Oral Care / Antiseptic
Hazard
Affected units
3,928

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: 6964
  • Lots: 56718
  • EXP 09/26/2017
  • 57387
  • 57414
  • 57423
  • EXP 11/13/2017
  • 58272
  • EXP 04/03/2018
  • 59592
  • EXP 07/16/2018
  • 60142
  • EXP 08/02/2018
  • 60541
  • EXP 09/04/2018
  • 60767
  • EXP 09/06/2018
  • 61159
  • EXP 09/11/2018
  • 61467

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 →

Related recalls

Same manufacturer · Sage Products Inc

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Same hazard · cross contamination

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