The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0393-2018·Announced 2018-02-21

Sage Q.Care Oral 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.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination risks in medical products.

Plain-English summary

Sage Products Inc. is voluntarily recalling 6,726 cases of the Q.Care Petite Size Oral Cleansing & Suctioning System. The product includes covered Yankauer suction handles, suction toothbrushes, oral swabs, and oropharyngeal suction catheters. The recall is due to a risk of cross-contamination, as the oral care solutions contained in the system 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. The recall covers specific lots with expiration dates ranging from September 2017 to April 2018, including lots 58121, 58771, 59394, 59400, 60389, 60453, 61087, 61121, and 61579.

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

The recalled product

Product
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Suction Handle and Y-Connector, 2 Petit Size Suction Toothbrush packages with Antiseptic Oral Rinse, 4 Petit Size Untreated Suction Oral Swab packages with Antiseptic Oral Rinse, 2 8 French…
Manufacturer
Sage Products Inc
Category
Medical Device — Oral Care
Hazard
Affected units
6,726

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 (18)

  • Product Code: 6704
  • Lots: 58121
  • EXP 09/19/2017
  • 58771
  • EXP 10/09/2017
  • 59394
  • EXP 11/15/2017
  • 59400
  • EXP 12/15/2017
  • 60389
  • EXP 01/08/2018
  • 60453
  • 61087
  • EXP 01/22/2018
  • 61121
  • EXP 03/05/2018
  • 61579
  • EXP 04/17/2018.

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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