Baxter Exactamix Pro 1200 Software Error Causes Medication Over-delivery
Baxter Healthcare is recalling the Baxter Exactamix Pro 1200 medication compounding device due to a software error that may cause ingredient over-delivery when using the 'Use Some Overfill' feature.
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 recall with no reported illnesses or deaths. The hazard is a confirmed software defect in medication delivery equipment that could cause ingredient over-delivery.
Plain-English summary
Baxter Healthcare Corporation has recalled the Baxter Exactamix Pro 1200 medication compounding device due to a software error identified in versions 2.0.8 and 2.1.8. When the 'Use Some Overfill' feature is used, the error may cause over-delivery of medication ingredients.
The recall involves 8 devices with specific serial numbers: PLD2314002, PLD2328001, PLD2328004, PLD2328042, PLD2314006, PLD2328002, PLD2328005, and LD2339005. The devices have been distributed to multiple U.S. states including 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 1200, REF EXM12DY
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 8
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 (9)
- UDI/DI 05413765588150
- Serial Numbers: PLD2314002
- PLD2328001
- PLD2328004
- PLD2328042
- PLD2314006
- PLD2328002
- PLD2328005
- LD2339005
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.
See all 2 products in this recall →Related recalls
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