The Recall Desk

FDA (Devices) recall action 86973

ICU Medical, Inc. recalled 4 products on 2021-02-17

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
2021-02-17
Critical
0
Units
30,000

Why these products were recalled

Due to the incorrect filter assembly.

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

  • ModerateFDA (Devices)··2021-02-17

    ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Filter Assembly Error

    ICU Medical is recalling 7,500 smallbore intravascular administration sets because of an incorrect filter assembly. The affected lots were distributed nationwide and in Belgium.

    Product
    60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from…
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2021-02-17

    ICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error

    ICU Medical is recalling 7,500 intravascular administration sets because of an incorrect filter assembly. The affected devices are distributed worldwide and across multiple U.S. states.

    Product
    154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the…
    Category
    Distribution
    19 states
  • HighFDA (Devices)··2021-02-17

    ICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error

    ICU Medical is recalling 7,500 intravascular administration sets because of an incorrect filter assembly. The affected devices were distributed in the U.S. and Belgium.

    Product
    60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system…
    Category
    Distribution
    19 states
  • ModerateFDA (Devices)··2021-02-17

    ICU Medical Recalls MicroCLAVE Intravascular Administration Sets Due to Filter Assembly Error

    ICU Medical is recalling 7,500 MicroCLAVE intravascular administration sets due to incorrect filter assembly. The affected lots were distributed nationwide in the U.S. and in Belgium.

    Product
    7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system…
    Category
    Distribution
    19 states