Baxter Recalls Mislabeled 5 mL Oral Dispensers Due to Packaging Errors
Baxter Healthcare is recalling 2,800 units of 5 mL oral dispensers because the individual pouches are mislabeled with the wrong product code and volume.
The agency’s classification
FDA (Devices): 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error on the packaging rather than a defect in the sterile device itself, fitting the criteria for moderate severity.
Plain-English summary
Baxter Healthcare Corporation is recalling 2,800 units of Sterile EXACTAMED Oral Dispensers, Clear, Individually Packaged, 5 mL (Product Code H93876105). The affected lot is Lot No. 1203395, with an expiration date of 11/30/2019.
The recall was initiated because the individual pouches containing the dispensers are mislabeled with the incorrect product code (H93876101) and an incorrect volume (1 mL). The actual product inside is the 5 mL dispenser.
The affected units were distributed domestically to Illinois, Massachusetts, Maryland, Ohio, South Dakota, Texas, Virginia, and Wisconsin, as well as internationally to Canada. Consumers and healthcare facilities should stop using the affected product and contact Baxter Healthcare Corporation for further instructions.
The recalled product
- Product
- Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Oral Dispensers
- Hazard
- Affected units
- 2,800
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 (2)
- Lot No. 1203395
- Expiration Date 11/30/2019
Distribution
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