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.
What this means for you
Illness, injury, or structural failure has been reported. 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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