The Recall Desk

FDA (Devices) recall action 65577

Baxter Healthcare Corp. recalled 3 products on 2013-07-17

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2013-07-17
Critical
0
Units
—

Why these products were recalled

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

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

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2013-07-17

    Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection

    Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap connection after storage.

    Product
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for sl
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-07-17

    Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection

    Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap and distal male Luer connection after storage.

    Product
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for sl
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-07-17

    Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection

    Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap and distal male Luer connection.

    Product
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for sl
    Category
    Distribution
    1 state