Sage Products Inc: Various Oral Care Systems and Solutions Recalled for Potential Cross Contamination

Agency Publication Date: February 9, 2018

Summary

Sage Products Inc. has recalled 470,694 units of various oral care solutions and suctioning systems, including Q.Care, Toothette, and Corinz brands, due to potential cross-contamination. These products were manufactured by a third-party supplier on equipment shared with non-pharmaceutical products, which could introduce unintended substances into the oral care rinses. The recall includes various kits and individual packets of oral debriding agents, antiseptic rinses, and mouthwashes used for oral hygiene in both home and clinical settings.

Risk

The shared manufacturing equipment creates a risk of cross-contamination with other non-pharmaceutical products. If a consumer uses a contaminated oral rinse, it could lead to irritation or unexpected reactions, particularly in patients with sensitive or compromised immune systems.

What You Should Do

Check your oral care product for the brand names Q.Care, Toothette, or Corinz and match the product code and lot number against the extensive list of affected units, such as Product Code 6434 (Lots 58519, 58536), 6065 (Lots 51450, 52551), or 6512 (Lots 51381, 51433).
Look for specific expiration dates on the packaging, which range from August 2017 to June 2019 depending on the specific product code.
Immediately stop using any oral care kit or solution that matches the affected product codes and lot numbers identified in this recall.
Contact your healthcare provider or pharmacist for guidance if you have used these products and have concerns about your health.
Return any unused or opened products to the pharmacy or place of purchase for a full refund.
Contact Sage Products Inc. at their Cary, Illinois facility for further instructions on returning products or obtaining a refund.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Refund for unused product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Q.Care, Oral Cleansing & Suctioning System q4

Model:

6434

UPC Codes:

618029830357

Lot Numbers:

58519 (Exp 10/02/2017)

58536 (Exp 10/02/2017)

59366 (Exp 11/13/2017)

60250 (Exp 01/02/2018)

60266 (Exp 01/02/2018)

60974 (Exp 02/23/2018)

61427 (Exp 03/30/2018)

Product: Q Care, Oral Cleansing & Suctioning System Corinz

Model:

6462

Lot Numbers:

55152 (Exp 08/28/2017)

57055 (Exp 09/26/2017)

57078 (Exp 11/13/2017)

58213 (Exp 12/22/2017)

58255 (Exp 04/02/2018)

59031 (Exp 04/03/2018)

59036 (Exp 06/15/2018)

59087 (Exp 06/15/2018)

59781 (Exp 07/30/2018)

59803 (Exp 07/16/2018)

Product: Toothette Oral Care Perox-A-Mint Solution (1.5 fl. oz./44 mL)

Model:

6065

UPC Codes:

618029800183

Lot Numbers:

51450 (Exp 9/19/2017)

52551 (Exp 11/30/2017)

53180 (Exp 1/16/2018)

54074 (Exp 3/11/2018)

54855 (Exp 4/28/2018)

010437 (Exp 1/12/2019)

020637 (Exp 2/14/2019)

51256 (Exp 5/27/2018)

081066 (Exp 8/25/2018)

090246 (Exp 9/8/2018)

110026 (Exp 11/8/2018)

110625 (Exp 11/19/2017)

Product: QCare Oral Cleansing and Suctioning System with Corinz (Kit)

Model:

6464

UPC Codes:

618029830777

Lot Numbers:

55175 (Exp 8/28/2017)

57086 (Exp 11/13/2017)

58011 (Exp 11/13/2017)

58604 (Exp 4/3/2018)

60373 (Exp 8/2/2018)

60590 (Exp 9/4/2018)

61540 (Exp 10/16/2018)

Product: QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) q2

Model:

6912

UPC Codes:

618029830166

Lot Numbers:

52736 (Exp 08/31/2017)

53363 (Exp 9/30/2017)

53916 (Exp 10/31/2017)

54487 (Exp 12/31/2017)

54686 (Exp 11/30/2017)

55546 (Exp 12/31/2017)

56348 (Exp 02/28/2018)

57506 (Exp 03/31/2018)

58696 (Exp 6/30/2018)

59456 (Exp 7/31/2018)

59766 (Exp 8/31/2018)

60416 (Exp 9/30/2018)

61780 (Exp 12/13/2018)

Product: Toothette Suction Toothbrush with Perox-A-Mint solution (NDC 53462-922-16)

Model:

6512

Lot Numbers:

51381 (Exp 8/8/2017)

51433 (Exp 8/15/2017)

51931 (Exp 9/12/17)

52754 (Exp 10/31/2017)

53326 (Exp 11/28/2017)

53826 (Exp 1/9/2018)

54266 (Exp 2/15/2018)

56030 (Exp 6/5/2018)

59762 (Exp 1/2/2019)

61715 (Exp 4/23/2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77992

Status: Resolved

Manufacturer: Sage Products Inc

Sold By: Hospitals; Healthcare facilities; Medical suppliers

Manufactured In: United States

Units Affected: 62 products (1182 kits; 7490 PACKETS; 1680 KITS; 48,003 cases; 38,792 cases; 9,006 cases; 966 cases; 2,199 cases; 4,061 cases; 2,429 cases; 835 cases; 25,409 cases; 849 cases; 94 cases; 637 cases; 14,753 cases; 15,644 cases; 945 cases; 2,548 cases; 640 cases; 879 cases; 887 cases; 5,217 cases; 2,938 cases; 2,194 cases; 6,200 cases; 13,041 cases; 5,579 cases; 9,110 cases; 852 cases; 42,628 cases; 11194 CASES; 5303 Cases; 6472 Cases; 8466 Cases; 10505 Cases; 2424 Cases; 25 Cases; 5138 Cases; 20 Cases; 2408 Cases; 4650 Cases; 4255 Cases; 672 Cases; 6726 Cases; 2017 Cases; 2970 Cases; 5085 Cases; 2468 Cases; 6130 Cases; 60 Cases; 82072 Cases; 60 Cases; 6461 Cases; 480 Cases; 16639 Cases; 3928 Cases; 633 Cases; 25 Cases; 1273 Cases; 4298 Cases; 150 Cases)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your oral care product for the brand names Q.Care, Toothette, or Corinz and match the product code and lot number against the extensive list of affected units, such as Product Code 6434 (Lots 58519, 58536), 6065 (Lots 51450, 52551), or 6512 (Lots 51381, 51433).

Look for specific expiration dates on the packaging, which range from August 2017 to June 2019 depending on the specific product code.

Immediately stop using any oral care kit or solution that matches the affected product codes and lot numbers identified in this recall.

Contact your healthcare provider or pharmacist for guidance if you have used these products and have concerns about your health.

Return any unused or opened products to the pharmacy or place of purchase for a full refund.

Contact Sage Products Inc. at their Cary, Illinois facility for further instructions on returning products or obtaining a refund.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Q.Care, Oral Cleansing & Suctioning System q4

Model:

6434

UPC Codes:

618029830357

Lot Numbers:

58519 (Exp 10/02/2017)

58536 (Exp 10/02/2017)

59366 (Exp 11/13/2017)

60250 (Exp 01/02/2018)

60266 (Exp 01/02/2018)

60974 (Exp 02/23/2018)

61427 (Exp 03/30/2018)

Product: Q Care, Oral Cleansing & Suctioning System Corinz

Model:

6462

Lot Numbers:

55152 (Exp 08/28/2017)

57055 (Exp 09/26/2017)

57078 (Exp 11/13/2017)

58213 (Exp 12/22/2017)

58255 (Exp 04/02/2018)

59031 (Exp 04/03/2018)

59036 (Exp 06/15/2018)

59087 (Exp 06/15/2018)

59781 (Exp 07/30/2018)

59803 (Exp 07/16/2018)

Product: Toothette Oral Care Perox-A-Mint Solution (1.5 fl. oz./44 mL)

Model:

6065

UPC Codes:

618029800183

Lot Numbers:

51450 (Exp 9/19/2017)

52551 (Exp 11/30/2017)

53180 (Exp 1/16/2018)

54074 (Exp 3/11/2018)

54855 (Exp 4/28/2018)

010437 (Exp 1/12/2019)

020637 (Exp 2/14/2019)

51256 (Exp 5/27/2018)

081066 (Exp 8/25/2018)

090246 (Exp 9/8/2018)

110026 (Exp 11/8/2018)

110625 (Exp 11/19/2017)

Product: QCare Oral Cleansing and Suctioning System with Corinz (Kit)

Model:

6464

UPC Codes:

618029830777

Lot Numbers:

55175 (Exp 8/28/2017)

57086 (Exp 11/13/2017)

58011 (Exp 11/13/2017)

58604 (Exp 4/3/2018)

60373 (Exp 8/2/2018)

60590 (Exp 9/4/2018)

61540 (Exp 10/16/2018)

Product: QCare Rx Oral Cleansing and Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) q2

Model:

6912

UPC Codes:

618029830166

Lot Numbers:

52736 (Exp 08/31/2017)

53363 (Exp 9/30/2017)

53916 (Exp 10/31/2017)

54487 (Exp 12/31/2017)

54686 (Exp 11/30/2017)

55546 (Exp 12/31/2017)

56348 (Exp 02/28/2018)

57506 (Exp 03/31/2018)

58696 (Exp 6/30/2018)

59456 (Exp 7/31/2018)

59766 (Exp 8/31/2018)

60416 (Exp 9/30/2018)

61780 (Exp 12/13/2018)

Product: Toothette Suction Toothbrush with Perox-A-Mint solution (NDC 53462-922-16)

Model:

6512

Lot Numbers:

51381 (Exp 8/8/2017)

51433 (Exp 8/15/2017)

51931 (Exp 9/12/17)

52754 (Exp 10/31/2017)

53326 (Exp 11/28/2017)

53826 (Exp 1/9/2018)

54266 (Exp 2/15/2018)

56030 (Exp 6/5/2018)

59762 (Exp 1/2/2019)

61715 (Exp 4/23/2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77992

Status: Resolved

Manufacturer: Sage Products Inc

Sold By: Hospitals; Healthcare facilities; Medical suppliers

Manufactured In: United States

Distributed To: Nationwide