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.
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 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
- Hazard
- medication-overdose-risk
- software-error
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
Distributed in 22 states:
- AL
- AZ
- CA
- FL
- GA
- IA
- KY
- MD
- MI
- MN
- MO
- NC
- NE
- NH
- NJ
- NV
- NY
- OR
- SD
- TX
- WA
- WI
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