Agency classClass IOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."

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…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Sets
Hazard: plastic-particulate
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 →

Same manufacturer · ICU Medical, Inc.

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Same hazard · plastic particulate