Sage Products Recalls Q Care RX Oral System Due to Cross Contamination
Sage Products is recalling 25 cases of Q Care RX Petite Oral Cleansing & Suctioning Systems 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination risks that could lead to adverse health consequences.
Plain-English summary
Sage Products Inc. is recalling 25 cases of the Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. The affected product includes specific components such as a Covered Yankauer, Y-Connector, suction toothbrushes, CHG Oral Rinse bottles, and oral swabs. The specific lot number is 58317 with an expiration date of 04/03/2018.
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 resulted in cross-contamination with other products. The agency has classified this recall as Class II.
The affected units were distributed nationwide in the USA and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Consumers and healthcare providers should stop using the product and contact Sage Products Inc. for further instructions or a refund.
The recalled product
- Product
- Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse. Contains 1 Covered Yankauer and Y-Connector, 2 Untreated Petite Suction Toothbrush packages, 2 Single dose bottles of 0.12% CHG Oral Rinse, 4 Petite Suction Oral Swab…
- Manufacturer
- Sage Products Inc
- Category
- Drug — Oral Care / Antiseptic
- Affected units
- 25
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 (3)
- Product Code: 6974-S
- Lots: 58317
- EXP 04/03/2018.
Distribution
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.
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