CLASS I Device recall · Reported 15 Aug 2012 · FDA Enforcement Report

Automix 3+3 Compounder System, product 2M8286 (115V) recalled

Baxter Healthcare is recalling Automix 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated, distributed nationwide in the US. The recall was initiated on 13 Jul 2012 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct codes 2M8286 and 2M8286K, all serial numbers

Quantity recalled3106 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2141-2012
FDA event ID: 62558
Recalling firm: Baxter Healthcare, Round Lake, IL
Classification: Class I
Status: Terminated
Recall initiated: 13 Jul 2012
FDA classified: 8 Aug 2012
Reported: 15 Aug 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

13 Jul 2012	Recall initiated by company
8 Aug 2012	Classified by FDA	+26 days
15 Aug 2012	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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 electrical failure, in which unexpected pump motor operations will occur. Also, the AUTOMIX system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 nutrition formulations via gravimetric weighing.

Where it was distributed

Worldwide Distribution - USA - Nationwide 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 United Kingdom.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Product codes 2M8286 and 2M8286K, all serial numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 62558

This product is part of a recall event; the main page for the event is Automix High Speed Compounder System, product 2M8077 recalled.

Reported	Class	Recall	Company	Reason	Where
15 Aug 2012	CLASS I	Automix High Speed Compounder System, product 2M8077 recalled	Baxter Healthcare	Device Malfunction	Nationwide
15 Aug 2012	CLASS I	Automix 3+3 Compounder with Accusource Monitoring System recalled	Baxter Healthcare	Device Malfunction	Nationwide
15 Aug 2012	CLASS I	Automix Plus High Speed Compounder System, product 2M8075 recalled	Baxter Healthcare	Device Malfunction	Nationwide

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