The Recall Desk
HighFDA (Devices)·Z-1095-2019·Announced 2019-04-24

ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate Risk

ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for administering cytotoxic medications with a potential for particulate contamination. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 300 units of the ChemoCLAVE Cytotoxic Medication Preparation and Delivery System, specifically the ChemoClave Viented Vial Spikes (20mm and 13mm) and related Oncology Kit components. The recall affects Lot Numbers 3846116 and 3855565.

The recall was initiated because there is a potential for these specific lots to contain plastic burr particulate. This particulate originates from the protective cap used during the assembly of the device. The affected products are used in IV administration sets for the preparation and patient administration of cytotoxic medications.

The affected devices were distributed worldwide, including nationwide in the United States and in Canada, France, and Singapore. Healthcare providers and facilities should stop using the affected lots and contact ICU Medical for instructions on return or replacement.

The recalled product

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 De
Manufacturer
ICU Medical, Inc.
Category
Medical Device — IV Administration Sets
Hazard
Affected units
300

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Numbers: 3846116
  • 3855565

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

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Same hazard · plastic particulate

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