Baxter Recalls Automix Plus High Speed Compounder Systems
Baxter Healthcare is recalling 840 Automix Plus High Speed Compounder Systems due to electrical failures that may cause incorrect responses or undetected stops.
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 medical device with a risk of harm (undetected failure or incorrect operation) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corp. is recalling 840 units of the AUTOMIX Plus High Speed Compounder System (product code 2M8075). These electromechanical devices are used to mix large volume parenteral nutrition formulations. The recall covers all serial numbers of this product code.
The recall was initiated because fluid ingress into the keypad of the control module may cause the device to generate incorrect responses to operator key presses. Additionally, the system may experience intermittent electrical failures, resulting in unexpected pump motor operations or the compounder stopping without an alarm, which may not be detected by the user.
The affected products were distributed nationwide in the United States, including Puerto Rico, and internationally to Brazil, Canada, Colombia, Costa Rica, Czech Republic, El Salvador, Egypt, Germany, Guatemala, Honduras, Luxembourg, Mexico, Panama, Saudi Arabia, Singapore, Switzerland, Taiwan, Trinidad, Turkey, United Arab Emirates, and the United Kingdom. Users should contact Baxter Healthcare for further instructions on how to proceed.
The recalled product
- Product
- AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulat
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 840
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)
- Product code 2M8075
- all serial numbers
Distribution
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corp. 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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