Baxter Recalls Exactamed Oral Dispensers Due to Mixed Sizes
Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 3 mL dispensers, risking inaccurate dosing.
What this means for you
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 III, which is typically associated with low risk of adverse health consequences. The hazard involves potential dosing errors due to mixed dispenser sizes, which is a moderate risk but does not meet the criteria for higher severity scores.
Plain-English summary
Baxter Healthcare Corporation is recalling Exactamed Oral Dispensers, 5 mL, Amber. The recall involves pharmacy packs and cost containment packs with specific reference numbers and lot numbers. The total quantity of affected units is 2,719,200 dispenser units.
The reason for the recall is that the 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers. This discrepancy could lead to inaccurate dose measurement and administration of liquid medication or nutrition.
The affected products were distributed worldwide, including nationwide in the United States and in Canada. Consumers and healthcare providers should check their inventory for the specific reference numbers and lot numbers listed in the recall notice and stop using the affected dispensers.
The recalled product
- Product
- EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK, REF H9388505, x 500; (c) COST CONTAINMENT, REF H93884205, x 1500 - Product Usage: Oral Liquid Dispensers are intended for the accurate dose measurement and clean intermittent adminis
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Oral Dispensers
- Hazard
- Affected units
- 2,719,200
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 (11)
- (a) REF H9388105
- Lot Numbers: B301N017P
- B301N070P
- B304N045P (b) REF H9388505
- Lot Numbers: B301N023P
- B301N049P
- B302N077P
- B303N108P (c) REF H93884205
- Lot Numbers: B301N056P
- B303N042P
- B307N015P
Distribution
Distributed nationwide across the United States.
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