FDA Device recall Z-2139-2012
AUTOMIX High Speed Compounder System, product 2M8077
- FDA Device
- Class I
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class I recall of AUTOMIX High Speed Compounder System, product 2M8077 by Baxter Healthcare, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2139-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-07-13 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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 via gravimetric weighing.
Reason
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.
Identifiers
| code_info | Product code 2M8077, all serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2139-2012%22
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