The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0385-2018·Announced 2018-02-21

Sage Products Recalls Oral Cleansing Systems Due to Cross-Contamination

Sage Products Inc is recalling Oral Cleansing & Suctioning Systems with 0.12% Chlorexidine Gluconate Oral Rinse because they 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, as it involves a risk of temporary or medically reversible adverse health consequences due to cross-contamination.

Plain-English summary

Sage Products Inc is recalling 2,424 cases of the Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. The product, identified by Product Code 6592, includes components such as a Covered Yankauer, Y-Connector, untreated suction toothbrushes, and single-dose bottles of oral rinse. The recall is driven by a cross-contamination risk identified during manufacturing.

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 usage creates a potential for cross-contamination with other products. The affected lots include 54071, 54664, 55007, 55866, 56487, 56516, 57057, 58756, 58766, 59618, 60036, and 60346, with expiration dates ranging from October 31, 2017, to August 31, 2019.

The affected products were distributed nationwide in the United States and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Consumers and healthcare facilities should stop using the recalled products and contact Sage Products Inc for further instructions or a refund. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, packages SYS W/CHG 10, Sage Products, Inc., 3909…
Manufacturer
Sage Products Inc
Category
Drug — Oral Care
Hazard
Affected units
2,424

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: 6592
  • Lots: 54071
  • EXP 10/31/2017
  • 54664
  • EXP 12/31/2017
  • 55007
  • EXP 11/30/2017
  • 55866
  • 56487
  • 56516
  • 57057
  • EXP 02/28/2018
  • 58756
  • 58766
  • EXP 06/30/2018
  • 59618
  • EXP 07/31/2018
  • 60036
  • 60346
  • EXP 08/31/2019.

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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