Baxter ExactaMed Oral Dispenser Recalled for Particulate Matter Contamination
Baxter Healthcare Corporation is recalling the ExactaMed 20 mL Oral Dispenser (Lot B301S356P) because it may contain particulate matter. The recall affects approximately 91,100 units distributed in the US.
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 3/5 (High).
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: FDA classified this as a Class II medical device recall. Although no illnesses or injuries have been reported, the potential for particulate matter in an oral medication dispenser creates a risk of harm through compromised medication delivery accuracy.
Plain-English summary
Baxter Healthcare Corporation is recalling the ExactaMed 20 mL Clear Pharmacy Pack oral dispensers (Lot Number B301S356P) because they may contain particulate matter. The contamination could affect the accuracy of medication delivery when the dispenser is used to administer oral medications.
Approximately 91,100 units of the recalled product were distributed in the United States. The product is used in pharmacy settings and by patients for precise measurement and administration of oral medications.
Consumers and healthcare providers who have this product should stop using it immediately. Contact Baxter Healthcare Corporation for instructions on returning the recalled units or obtaining replacement product.
The recalled product
- Product
- ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 91,100
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 (1)
- Lot Number B301S356P
Distribution
Distribution scope not specified by the agency.
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