Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-2432-2019·Announced 2019-09-04

Baxter Recalls Exactamed Oral Dispensers Due to Mixed Sizes

Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 10 mL dispensers.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a labeling/packaging error (mixed sizes) rather than a direct contamination or structural failure.

Plain-English summary

Baxter Healthcare Corporation is recalling Exactamed 5 mL Oral Dispensers, Amber, in pharmacy packs. The recall involves specific reference numbers and lot numbers for 500-count, 100-count, and 1500-count packs.

The recall was initiated because the 5 mL pharmacy packs may contain both 5 mL and 10 mL oral dispensers. This discrepancy in dispenser size within a single package could lead to medication dosing errors.

The affected products were distributed nationwide. 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: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Syringes / Dispensers
Hazard: mis-labeling
dosing-error
Affected units: 2,192,000

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 (12)

REF H9388105
Lot Numbers: B301N017P
B301N070P
B302M338P
B304N045P REF H9388505
Lot Numbers: B301N023P
B301N049P
B302N077P REF H93884205
Lot Numbers: B301N056P
B302M333P
B303N042P
B307N015P

Distribution

Distributed nationwide across the United States.

Same manufacturer · Baxter Healthcare Corporation

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