The Recall Desk
SevereFDA (Devices)·Z-2139-2012·Announced 2012-08-15

Baxter Recalls Automix High Speed Compounder Systems Due to Electrical Failures

Baxter Healthcare is recalling 270 Automix High Speed Compounder Systems worldwide due to potential electrical failures and incorrect device responses.

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: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Baxter Healthcare Corp. is recalling 270 units of the AUTOMIX High Speed Compounder System, product code 2M8077. 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 go undetected by the user.

The affected units 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.

The recalled product

Product
AUTOMIX High Speed Compounder System, product 2M8077; 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 formulations
Manufacturer
Baxter Healthcare Corp.
Category
Medical Device — Nutrition Compounder
Hazard
Affected units
270

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 2M8077
  • 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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