Z-1094-2019 Class I Terminated
FDA device recall Z-1094-2019 was initiated by ICU Medical, Inc. on February 21, 2019 and is designated Class I. 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. The recall status is terminated (terminated June 4, 2024). Affected quantity: 18150 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2019
- Initiation Date
- February 21, 2019
- Termination Date
- June 4, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18150 devices
Product Description
icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. 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.
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.
Distribution Pattern
Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
Code Information
Lot Numbers: 3846114, 3855564, 3902719, 3961122