The Recall Desk

FDA (Devices) recall action 80014

Baxter Healthcare Corporation recalled 2 products on 2018-06-13

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
2018-06-13
Critical
0
Units
456,850

Why these products were recalled

The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.

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

  • ModerateFDA (Devices)··2018-06-13

    Baxter SIGMA Spectrum Infusion Pump Instructions for Use Update

    Baxter Healthcare is updating the Instructions for Use for SIGMA Spectrum Infusion Pumps to correct a discrepancy regarding the height of secondary infusion hangers.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include phar
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-06-13

    Baxter SIGMA Spectrum Infusion Pump Recall for Instructional Mismatch

    Baxter is recalling SIGMA Spectrum Infusion Pumps because the instructions for use specify a 20-inch bag drop, but the firm supplies 12.5-inch hangers.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may
    Category
    Distribution
    0 states