Overview of recall records associated with ICU Medical, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 340, Class I: 20.
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.
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.
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in…
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in…
Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in…
There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
Potential for leakage due to defect in the thermoset check valve component.
Potential for leakage due to defect in the thermoset check valve component.
Potential for leakage due to defect in the thermoset check valve component.
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
Lack of Assurance of Sterility; bags have the potential to leak
Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the…
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
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.
