Reported Aug 15, 2012 · Terminated
AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product…
Baxter Healthcare Corp.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · Rt. 120 & Wilson Rd · Round Lake, IL · 60073
Is this the product you have?
- AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders
- Product UsageThe Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing
- Lot codes and dates
- Product code 2M8287, all serial numbers
- Amount recalled
- 950 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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