The Recall Desk

FDA (Devices) recall action 87703

ICU Medical, Inc. recalled 26 products on 2021-05-19

The FDA (Devices) publishes a recall like this one as 26 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 26 pages.

Products
26
Announced
2021-05-19
Critical
0
Units
—

Why these products were recalled

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

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

States named across these recalls

1–25 of 26

  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the admi
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls IV Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of IV administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls 20mL Syringes Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of 20mL syringes with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Leakage Defect

    ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.

    Product
    REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2021-05-19

    ICU Medical Recalls Spiros Transfer Sets Due to Molding Defect

    ICU Medical is recalling Spiros transfer sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted in
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect

    ICU Medical is recalling specific lots of Spinning Spiros male luers because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or c
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Spinning Spiros Syringes Due to Leakage Defect

    ICU Medical is recalling specific lots of 60mL Spinning Spiros syringes because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Spiros Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Smallbore Extension Sets Due to Molding Defect

    ICU Medical is recalling specific lots of smallbore extension sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administ
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Bag Spike Adapters Due to Molding Defect

    ICU Medical is recalling specific lots of Bag Spike Adapters due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2021-05-19

    ICU Medical Recalls Sprios Male Luer Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted in
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Spinning Spiros Closed Male Luer Due to Leakage

    ICU Medical is recalling certain lots of Spinning Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect

    ICU Medical is recalling specific lots of Oncology Kits with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Spiros Closed Male Luer Due to Leakage Defect

    ICU Medical is recalling Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect

    ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.

    Product
    REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2021-05-19

    ICU Medical Recalls Spiros Male Luer Extensions Due to Leakage

    ICU Medical is recalling Spiros male luer extensions due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2021-05-19

    ICU Medical Recalls Sprios IV Adapters Due to Leakage Defect

    ICU Medical is recalling specific lots of Sprios IV adapters because a molding defect may cause leakage in the inactivated position.

    Product
    REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Spiros Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or c
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or cathe
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect and Leakage

    ICU Medical is recalling specific lots of Oncology Kits due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
    Category
    Distribution
    39 states
  • HighFDA (Devices)··2021-05-19

    ICU Medical Recalls Sprios Male Luer Administration Sets Due to Leakage

    ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserte
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Oncology Kits Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a pa
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect

    ICU Medical is recalling specific lots of REF CL3538 Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle
    Category
    Distribution
    39 states
  • ModerateFDA (Devices)··2021-05-19

    ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Leakage Defect

    ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needl
    Category
    Distribution
    39 states