The Recall Desk
HighFDA (Drugs)·D-0348-2018·Announced 2018-02-21

Sage Products Recalls Q.Care Oral Cleansing Kits Due to Cross-Contamination

Sage Products is recalling 1,182 Q.Care Oral Cleansing & Suctioning System kits because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device/pharmaceutical solution) where cross-contamination with non-pharmaceutical products presents a potential safety risk, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Sage Products Inc is voluntarily recalling 1,182 units of the Q.Care, Oral Cleansing & Suctioning System q4. The product, which includes covered Yankauer tips, suction toothbrushes, and oral swabs with solutions, 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 was initiated due to cross-contamination with other products. The oral care solutions contained in the kits were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products. This shared equipment usage poses a risk of contamination that is not appropriate for pharmaceutical or medical-grade oral care solutions.

Consumers who have purchased these kits should stop using them immediately. Affected lots include 58519, 58536, 60250, 60266, 60974, and 61427, with expiration dates ranging from October 2017 to March 2018. Consumers should contact Sage Products Inc for further instructions on how to return or dispose of the product.

The recalled product

Product
Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages and Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution. Manufactured by: Sage Products, LLC., 3909 Three Oaks Road, Cary, IL 60
Manufacturer
Sage Products Inc
Category
Medical Device — Oral Care
Hazard
Affected units
1,182

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 (13)

  • Product Code: 6434
  • Lots: 58519
  • 58536
  • EXP 10/02/2017
  • 59366
  • EXP 11/13/2017
  • 60250
  • 60266
  • EXP 01/02/2018
  • 60974
  • EXP 02/23/2018
  • 61427
  • EXP 03/30/2018.

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

See all →

Same hazard · cross contamination

See all →