Exact FDA event identifier

Event 82291

7 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 21, 2019
Product types: Device
Classifications: Class I
Statuses: Terminated
Recalling firm wording: ICU Medical, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . 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.

Z-1092-2019

Recall number: Z-1092-2019
Initiated: February 21, 2019
Classification: Class I
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 27200 devices

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers: 3866759, 3872252, 3910046, 3910627

Distribution pattern

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

device · product 2 of 7

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.

Z-1093-2019

Recall number: Z-1093-2019
Initiated: February 21, 2019
Classification: Class I
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 60500 devices

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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

device · product 3 of 7

icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. 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.

Z-1094-2019

Recall number: Z-1094-2019
Initiated: February 21, 2019
Classification: Class I
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 18150 devices

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers: 3846114, 3855564, 3902719, 3961122

Distribution pattern

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

device · product 4 of 7

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.

Z-1095-2019

Recall number: Z-1095-2019
Initiated: February 21, 2019
Classification: Class I
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 300 devices

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers: 3846116, 3855565

Distribution pattern

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

device · product 5 of 7

icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

Z-1096-2019

Recall number: Z-1096-2019
Initiated: February 21, 2019
Classification: Class I
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 160775 devices

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

(a) REF CL,-80S, Lot numbers: 3824204, 3824209, 3826652, 3828646, 3829557, 3836196, 3836811, 3853995, 3853997, 3866764, 3866766, 3872065, 3872072, 3872085, 3872093, 3872433, 3872444, 3910642, 3920773, 3932270, 3945868, 3946776 (b) REF CL-80S-10 (10 units), Lot Numbers: 3820519, 3820522, 3839240, 3839241, 3844783, 3844784, 3854004, 3854005, 3910656, 3932907, 3946771, 3946772

Distribution pattern

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

device · product 6 of 7

icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

Z-1097-2019

Recall number: Z-1097-2019
Initiated: February 21, 2019
Classification: Class I
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 23800 devices

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

(a) REF CL-80S-4, Lot Numbers: 3820520, 3820521, 3844785 (b) REF CL-80S-5, Lot Numbers: 3820516, 3820523, 3839238, 3839239, 3844781, 3844782, 3853998, 3853999, 3866769, 3866770, 3872090, 3910645, 3932908, 3932910, 3946770, 3951236

Distribution pattern

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

device · product 7 of 7

SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. 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.

Z-1098-2019

Recall number: Z-1098-2019
Initiated: February 21, 2019
Classification: Class I
Status: Terminated
Recalling firm: ICU Medical, Inc.
Quantity: 3500 units

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

particulate

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers: 3872008, 3899761

Distribution pattern

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