The Recall Desk
HighFDA (Devices)·Z-2142-2012·Announced 2012-08-15

Baxter Recalls Automix 3+3 Compounders Due to Electrical Failures

Baxter Healthcare is recalling 950 Automix 3+3 Compounders because fluid ingress can cause incorrect responses, unexpected pump operations, or silent 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 high-risk medical device where electrical failures could lead to incorrect dosing or undetected stops, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corp. is recalling 950 units of the AUTOMIX 3+3 Compounder with Accusource Monitoring System (product code 2M8287). These devices are electromechanical positive displacement fluid compounders used to mix large volume parenteral nutrition formulations. The recall covers all serial numbers of this product code.

The recall is due to a risk of fluid ingress into the control module's keypad. This issue can cause the device to generate an incorrect response to an operator's key press. Additionally, the system may experience intermittent electrical failures, leading to unexpected pump motor operations or the compounder stopping without an alarm, which may go undetected by the user.

The affected units were distributed worldwide, including 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 Corp. for instructions on how to proceed.

The recalled product

Product
AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nut
Manufacturer
Baxter Healthcare Corp.
Category
Medical Device — Nutrition Compounder
Hazard
Affected units
950

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 2M8287
  • all serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 4 products in this recall →

Related recalls

Same manufacturer · Baxter Healthcare Corp.

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Same hazard · electrical failure

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