The Recall Desk

FDA (Devices) recall action 80427

ICU Medical, Inc. recalled 53 products on 2018-08-15

The FDA (Devices) publishes a recall like this one as 53 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 53 pages.

Products
53
Announced
2018-08-15
Critical
0
Units
8,480,848

Why these products were recalled

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

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

1–25 of 53

  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 119-inch blood sets labeled as DEHP-free because they may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.

    Product
    119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood tubing sets because they are labeled as not containing DEHP, but may contain small amounts of the chemical.

    Product
    140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Lopez Valve Devices Due to DEHP Labeling Error

    ICU Medical is recalling Lopez Valve, Sterile blood tubing accessories because some units were incorrectly labeled as not containing DEHP, though they may contain small amounts.

    Product
    Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 126-inch Y-Type Blood Sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling

    ICU Medical is recalling specific blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error

    ICU Medical is recalling 160,016 units of blood tubing accessories because some were labeled as not containing DEHP, despite potentially containing small amounts.

    Product
    132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Lopez Valve Recall for Incorrect DEHP Labeling

    ICU Medical is recalling Lopez Valves with Red Caps because they were labeled as DEHP-free but may contain small amounts of DEHP.

    Product
    Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific blood tubing sets because they are labeled as not containing DEHP, even though they may contain small amounts of the chemical.

    Product
    112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 units of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers devices distributed in the US and several international countries.

    Product
    84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood set units because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as DEHP-free but may contain small amounts of the chemical.

    Product
    121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Blood Set Recall for Incorrect DEHP Labeling

    ICU Medical is recalling blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.

    Product
    32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling

    ICU Medical is recalling specific blood set accessories because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP.

    Product
    139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pierced Port, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, despite potentially containing small amounts of the chemical.

    Product
    117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling

    ICU Medical is recalling specific lots of Y-Type Blood Sets because they are labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
    Category
    Distribution
    28 states
  • ModerateFDA (Devices)··2018-08-15

    ICU Medical Recalls Blood Administration Sets Due to DEHP Labeling Error

    ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free, though they may contain small amounts of DEHP.

    Product
    100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or…
    Category
    Distribution
    28 states