The Recall Desk

FDA (Devices) recall action 82291

ICU Medical, Inc. recalled 7 products on 2019-04-24

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2019-04-24
Critical
0
Units
294,225

Why these products were recalled

There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

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.

1–7 of 7

  • SevereFDA (Devices)··2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoClave Vented Vial Spikes because they may contain plastic burr particulate from the protective cap.

    Product
    icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap.

    Product
    SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-04-24

    ICU Medical Recalls ChemoLock Devices Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoLock devices because they may contain plastic burr particulate from the protective cap.

    Product
    icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate Risk

    ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap.

    Product
    icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap used during assembly.

    Product
    icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-04-24

    ICU Medical Recalls ChemoLock Vial Spikes Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoLock Vial Spikes because they may contain plastic burr particulate from the protective cap.

    Product
    icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Burr Risk

    ICU Medical is recalling certain lots of ChemoClave Vented Vial Spikes because plastic burrs from the protective cap may contaminate the device.

    Product
    icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne…
    Category
    Distribution
    0 states