The Recall Desk
SevereFDA (Drugs)·D-0406-2018·Announced 2018-02-21

Sage Q Care RX Oral System Recalled for Cross Contamination

Sage Products is recalling Q Care RX Oral Systems because they were manufactured on equipment shared with non-pharmaceutical products, posing a cross-contamination risk.

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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination or significant injury risks.

Plain-English summary

Sage Products Inc. is recalling 633 cases of the Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. The affected product includes covered Yankauer and Y-Connectors, suction toothbrushes, CHG oral rinse bottles, oral swabs, and oropharyngeal suction catheters.

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 created a risk of cross-contamination with other products. The agency has classified this recall as Class II.

The affected units 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 providers should stop using the product and contact Sage Products Inc. for instructions on return or disposal.

The recalled product

Product
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab package
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
633

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 (8)

  • Product Code: 6974
  • Lots: 58322
  • 58649
  • EXP 04/03/2018
  • 60186
  • EXP 08/02/2018
  • 60747
  • EXP 09/06/2018.

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 →

Related recalls

Same manufacturer · Sage Products Inc

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Same hazard · cross contamination

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