ICU Medical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1095-2019)

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 Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.

Product Classification:

Class I

Date Initiated: February 21, 2019

Date Posted: April 24, 2019

Recall Number: Z-1095-2019

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: 300 devices

Code Information:

Lot Numbers: 3846116, 3855565

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated