CLASS I Device recall · Reported 24 Apr 2019 · FDA Enforcement Report

icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap recalled

ICU Medical is recalling icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter, distributed nationwide in the US. The recall was initiated on 21 Feb 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Numbers: 3846116, 3855565

Quantity recalled300 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1095-2019
FDA event ID: 82291
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class I
Status: Terminated
Recall initiated: 21 Feb 2019
FDA classified: 15 Apr 2019
Reported: 24 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Device type: Infusion Pumps

Timeline

21 Feb 2019	Recall initiated by company
15 Apr 2019	Classified by FDA	+53 days
24 Apr 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.

Nationwide

Questions about this recall

Is icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter recalled?

Yes. ICU Medical recalled icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter on 21 Feb 2019. The recall is Class I and its status is Terminated. Recall number Z-1095-2019.

Why was it recalled?

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.

Which lots are affected?

Lot Numbers: 3846116, 3855565

Where was it sold?

Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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