Baxter Recalls ExactaMix Compounders Due to Battery Clock Reset
Baxter Healthcare is recalling ExactaMix 1200 and 2400 compounders because a battery failure causes the internal clock to reset to midnight on December 31, 2010.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II. The hazard involves a clock reset due to battery failure, which is a functional defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Baxter Healthcare is recalling specific ExactaMix 1200 and 2400 automated compounding devices. These devices are used as automated pumping systems to compound multiple sterile ingredients into a finished solution.
The recall is due to a complementary metal oxide semi-conductor (CMOS) battery failure. This failure results in the internal clock of the device resetting to midnight on December 31, 2010.
The recall involves 753 units distributed worldwide, including the United States (nationwide and Puerto Rico), Canada, Latin America, Europe/Middle East/Africa, and Taiwan. Affected units include ExactaMix 1200 serial numbers 45004-45481 and ExactaMix 2400 serial numbers 40005-40335.
The recalled product
- Product
- ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
- Manufacturer
- Baxa Corporation
- Affected units
- 753
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 (2)
- ExactaMix 1200 serial numbers 45004-45481 (sequentially)
- and ExactaMix 2400 serial numbers 40005-40335.
Distribution
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