ICU Medical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1097-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

Product Classification:

Class I

Date Initiated: February 21, 2019

Date Posted: April 24, 2019

Recall Number: Z-1097-2019

Event ID: 82291

Reason for Recall:

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.

Status: Terminated

Product Quantity: 23800 devices

Code Information:

(a) REF CL-80S-4, Lot Numbers: 3820520, 3820521, 3844785 (b) REF CL-80S-5, Lot Numbers: 3820516, 3820523, 3839238, 3839239, 3844781, 3844782, 3853998, 3853999, 3866769, 3866770, 3872090, 3910645, 3932908, 3932910, 3946770, 3951236

Distribution Pattern:

Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated