Baxter Exactamix Compounder Recall Due to Software Configuration Error
Baxter Healthcare is recalling Exactamix 1200 and 2400 Compounders because a software error may prevent pump tube flushing, risking cross-contamination of IV solutions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a software defect could lead to cross-contamination of IV solutions. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Baxter Healthcare Corp. is recalling 1,758 units of the Exactamix 1200 and 2400 Compounders, including specific model numbers and replacement displays. These devices are automated pumping systems used to compound multiple sterile ingredients into a finished solution in a single patient IV administration bag. The recall covers units distributed nationwide in the United States.
The recall was initiated because a software defect exists in the Configuration Editor. If the universal ingredient (UI) in an active configuration is changed using this tool, the software fails to initiate a flush of the outlet pump tube. This failure could result in the original universal ingredient remaining in the tube and being delivered into the next bag, potentially causing cross-contamination of the IV solution.
Healthcare facilities and users of these devices should contact Baxter Healthcare for instructions on how to resolve the issue or replace the affected units. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds mu
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 1,758
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 (6)
- model numbers 1200-DY
- 1200-DX
- 1200-DYR and 1200-DXR
- EXACTAMIX 2400 Compounder model numbers 2400-DY
- 2400-DX
- 2400-DYR and 2400-DYX
Distribution
Distributed nationwide across the United States.
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