The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2141-2012·Announced 2012-08-15

Baxter Recalls Automix 3+3 Compounder Systems Due to Electrical Failures

Baxter Healthcare is recalling 3,106 Automix 3+3 Compounder Systems because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX operator's key press. Also, the AUTOMIX system may experience an intermittent…"

Plain-English summary

Baxter Healthcare Corp. is recalling 3,106 units of the AUTOMIX 3+3 Compounder System, product codes 2M8286 (115V) and 2M8286K (230V). These automated nutrition compounders are electromechanical devices used to mix large volume parenteral nutrition formulations. The recall covers all serial numbers for these product codes.

The recall is due to a risk of fluid ingress into the control module's keypad. This issue may cause the device to generate an incorrect response to operator key presses. Additionally, the system may experience intermittent electrical failures that result in unexpected pump motor operations or cause the compounder to stop working without an alarm, which may not be detected by the user.

The affected devices 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 stop using the devices and contact Baxter Healthcare for instructions on repair or replacement.

The recalled product

Product
AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral…
Manufacturer
Baxter Healthcare Corp.
Category
Medical Device — Nutrition Compounder
Hazard
Affected units
3,106

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 codes 2M8286 and 2M8286K
  • 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 →

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