Baxter Exactamix Pro 2400 Recalled for Software Error Causing Ingredient Over-Delivery
Baxter is recalling Exactamix Pro 2400 pharmacy mixing devices due to a software error in versions 2.0.8 and 2.1.8 that may cause over-delivery of ingredients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I medical device recalls require a minimum severity score of 4 per the rules. Although no deaths or serious injuries have been reported, the potential for incorrect medication dosing in pharmacy compounding justifies a severe classification.
Plain-English summary
Baxter Healthcare Corporation is recalling the Exactamix Pro 2400 (REF EXM24DY) automated pharmacy mixing device. A total of 67 devices are affected.
A software error has been identified in device software versions 2.0.8 and 2.1.8. When using the 'Use Some Overfill' feature, the error may cause over-delivery of an ingredient, resulting in redundant ingredient delivery beyond the prescribed overfill volume.
The affected devices were distributed to healthcare facilities across 22 U.S. states: Alabama, Arizona, California, Florida, Georgia, Iowa, Kentucky, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Oregon, South Dakota, Texas, Washington, and Wisconsin.
The recalled product
- Product
- Baxter Exactamix Pro 2400, REF EXM24DY
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 67
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 (20)
- UDI/DI 05413765588136
- Serial Numbers: PLD0019873
- PLD2311023
- PLD2325014
- PLD2339015
- PLD0019879
- PLD2311029
- PLD2325016
- PLD2339016
- PLD2245007
- PLD2311031
- PLD2325017
- PLD2339017
- PLD2303007
- PLD2311034
- PLD2325018
- PLD2339018
- PLD2303008
- PLD2311036
- PLD2325019
Distribution
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) 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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