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

icumedical ChemoClave Vented Vial Spike recalled

ICU Medical is recalling icumedical ChemoClave Vented Vial Spike, 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: 3826647, 3826648, 3826844, 3827598, 3839689, 3839690, 3854000, 3854001, 3866761, 3873006, 3936065, 3952512

Quantity recalled60500 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-1093-2019
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 ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

Where it was distributed

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

Nationwide

Questions about this recall

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: 3826647, 3826648, 3826844, 3827598, 3839689, 3839690, 3854000, 3854001, 3866761, 3873006, 3936065, 3952512

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

Other products in this recall event

6 other products · FDA event 82291

This product is part of a recall event; the main page for the event is icumedical ChemoLock Closed Vial Spike w/Skirt, (a) recalled.

Reported	Class	Recall	Company	Reason	Where
24 Apr 2019	CLASS I	icumedical ChemoLock Closed Vial Spike w/Skirt, (a) recalled	ICU Medical	Particulate Matter	Nationwide
24 Apr 2019	CLASS I	SetSource ChemoClave Vented Vial Spike recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
24 Apr 2019	CLASS I	icumedical ChemoClave Vented Vial Spike recalled	ICU Medical	Particulate Matter	Nationwide
24 Apr 2019	CLASS I	icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap recalled	ICU Medical	Particulate Matter	Nationwide
24 Apr 2019	CLASS I	icumedical ChemoLock, (a) recalled	ICU Medical	Particulate Matter	Nationwide
24 Apr 2019	CLASS I	icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap recalled	ICU Medical	Particulate Matter	Nationwide

More recalls from ICU Medical

All 654

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	Hotline Fluid Warming Set, single use device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
17 Jun 2026Device	CLASS II	Plum Solo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide

Other Infusion Pumps recalls

All 546

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide