ICU Medical, Inc. Recalls — U.S. Recall Records

Recall history in this database

Classification mix: Class II: 340, Class I: 20.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0143-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0131-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets recall — FDA Z-0145-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0146-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0144-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0141-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets recall — FDA Z-0139-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets recall — FDA Z-0126-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets recall — FDA Z-0138-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0142-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets recall — FDA Z-0128-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets recall — FDA Z-0136-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0135-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0140-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0132-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0133-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0147-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0129-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets recall — FDA Z-0137-2020

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceApr 24, 2019

ICU Medical icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) recall — FDA Z-1097-2019

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.

Class IFDA: TerminatedICU Medical, Inc.

Medical DeviceApr 24, 2019

ICU Medical SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148 recall — FDA Z-1098-2019

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.

Class IFDA: TerminatedICU Medical, Inc.

Medical DeviceApr 24, 2019

ICU Medical icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S recall — FDA Z-1093-2019

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.

Class IFDA: TerminatedICU Medical, Inc.

Medical DeviceApr 24, 2019

ICU Medical icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S recall — FDA Z-1092-2019

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.

Class IFDA: TerminatedICU Medical, Inc.

Medical DeviceApr 24, 2019

ICU Medical icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp recall — FDA Z-1095-2019

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.

Class IFDA: TerminatedICU Medical, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies ICU Medical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.