Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2139-2012 — 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 weig

U.S. FDA — Device Enforcement · United States · 2012-07-13 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2139-2012
Date of alert: 2012-07-13
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Baxter Healthcare Corp.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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