Device product
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.
Z-1095-2019
Product summary
- Event
- Event 82291
- Status
- Terminated
- Classification
- Class I
- Quantity
- 300 devices
- Official record key
device-enforcement:Z-1095-2019
Official wording
Reason: 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.
Code information: Lot Numbers: 3846116, 3855565
Distribution pattern: Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
Derived failure modes
-
Foreign material or chemical contamination
particulate