ICU Medical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1098-2019)

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:

SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

Product Classification:

Class I

Date Initiated: February 21, 2019

Date Posted: April 24, 2019

Recall Number: Z-1098-2019

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: 3500 units

Code Information:

Lot Numbers: 3872008, 3899761

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated