The Recall Desk

FDA (Devices) recall action 62558

Baxter Healthcare Corp. recalled 4 products on 2012-08-15

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2012-08-15
Critical
0
Units
5,166

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • SevereFDA (Devices)··2012-08-15

    Baxter Recalls Automix High Speed Compounder Systems Due to Electrical Failures

    Baxter Healthcare is recalling 270 Automix High Speed Compounder Systems worldwide due to potential electrical failures and incorrect device responses.

    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
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-08-15

    Baxter Recalls Automix Plus High Speed Compounder Systems

    Baxter Healthcare is recalling 840 Automix Plus High Speed Compounder Systems due to electrical failures that may cause incorrect responses or undetected stops.

    Product
    AUTOMIX Plus High Speed Compounder System, product 2M8075; 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 formulat
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-08-15

    Baxter Recalls Automix 3+3 Compounders Due to Electrical Failures

    Baxter Healthcare is recalling 950 Automix 3+3 Compounders because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.

    Product
    AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nut
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-08-15

    Baxter Recalls Automix 3+3 Compounder Systems Due to Electrical Failures

    Baxter Healthcare is recalling 3,106 Automix 3+3 Compounder Systems because fluid ingress can cause incorrect responses, unexpected pump operations, or silent stops.

    Product
    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 nutr
    Category
    Distribution
    1 state