The Recall Desk

FDA (Devices) recall action 83138

Fenwal Inc recalled 2 products on 2019-08-21

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2019-08-21
Critical
0
Units
9,544

Why these products were recalled

The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and 1.1 of Vigilant DrugLib

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.

1–2 of 2

  • SevereFDA (Devices)··2019-08-21

    Fenwal Recalls Vigilant Agilia and Volumat MC Agilia Infusion Pump Software

    Fenwal Inc is recalling 83 units of Vigilant Agilia and Volumat MC Agilia software to correct four anomalies and an alarm priority issue.

    Product
    Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software that, when used in combination with Volumat MC Agilia infusion pumps, is intended to reduce drug administration errors at the bedside. Vigi
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    Distribution
    0 states
  • ModerateFDA (Devices)··2019-08-21

    Fenwal Volumat MC Agilia Infusion Pump Software Recall

    Fenwal Inc is recalling Volumat MC Agilia infusion pumps to correct four software anomalies and an alarm priority issue in specific software versions.

    Product
    VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospit
    Category
    Distribution
    0 states