AUTOMIX High Speed Compounder System — Class I medical device recall Z-2139-2012
Terminated recall by Baxter Healthcare Corp., reported 2012-08-15, distributed nationwide. After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUTOMIX may gene
| Recall number | Z-2139-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Round Lake, IL, United States |
| Recall initiated | 2012-07-13 |
| Classified | 2012-08-08 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2017-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BR, CA, CH, CO, CR, CZ, DE, EG, GB, GT, HN, LU, MX, PA, SA, SG, SV, TR, TT, TW |
| Quantity | 270 units |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2139-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.