The Recall Desk
SevereFDA (Drugs)·D-0375-2018·Announced 2018-02-21

Sage Q CARE Oral System Recalled for Cross-Contamination Risk

Sage Products is recalling Q CARE q4 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 recall is classified as FDA Class II. 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 snippet.

Plain-English summary

Sage Products Inc. is recalling 13,041 cases of the Q CARE q4 Oral Cleansing & Suctioning System. The product includes a covered Yankauer, Y-connector, suction toothbrushes with antiplaque solution, suction oral swabs with antiseptic oral rinse, and oropharyngeal suction catheters. 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 lots were 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, ranging from 09/18/2017 to 04/27/2018.

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

The recalled product

Product
Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Thr
Manufacturer
Sage Products Inc
Category
Medical Device — Oral Care / Suctioning
Hazard
Affected units
13,041

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: 6414
  • Lots: 57847
  • EXP 09/18/2017
  • 57852
  • 57875
  • EXP 08/14/2017
  • 58246
  • EXP 09/20/2017
  • 58802
  • 58851
  • EXP 10/09/2017
  • 58924
  • 59091
  • 59116
  • EXP 11/03/2017
  • 59494
  • EXP 11/27/2017
  • 60123
  • EXP 01/02/2018
  • 60466

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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Same hazard · cross contamination

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