icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoC...

FDA Device Recall #Z-1095-2019 — Class I — February 21, 2019

Recall Summary

Recall Number Z-1095-2019
Classification Class I — Serious risk
Date Initiated February 21, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm ICU Medical, Inc.
Location San Clemente, CA
Product Type Devices
Quantity 300 devices

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.

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.

Lot / Code Information

Lot Numbers: 3846116, 3855565

Other Recalls from ICU Medical, Inc.

Recall # Classification Product Date
Z-1111-2026 Class II Tego Connector: REF: 011-D1000, 01C-D1000, 055-... Dec 19, 2025
Z-1094-2026 Class II Plum Duo Infusion System, List Number 40002-04-01 Dec 15, 2025
Z-1119-2026 Class II ICU Medical Plum Duo Precision IV Pump, List Nu... Dec 15, 2025
Z-1120-2026 Class II ICU Medical Plum Solo Precision IV Pump, List N... Dec 15, 2025
Z-1118-2026 Class II ICU Medical Plum Duo Infusion Pump, List Number... Dec 15, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.