Device recall: icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a…

Class I FDA enforcement event 82291. Recall start date: 21 Feb 2019. Status in the FDA record: Terminated. Termination date: 4 Jun 2024.

Reason for recall, in the words of FDA

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.

Class I, in the words of FDA

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

ICU Medical, Inc. started this device recall on 21 Feb 2019. The firm address in the FDA record is in San Clemente, CA. FDA put the recall in Class I. FDA event 82291 has 7 product records. The first FDA enforcement report date is 24 Apr 2019. The record gives the status Terminated, with the termination date 4 Jun 2024.

FDA enforcement report The 7 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

ICU Medical, Inc., San Clemente, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

7 product records in the event.

FDA event 82291: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1092-2019	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…	27200 devices	Class I	Terminated	24 Apr 2019
Z-1093-2019	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…	60500 devices	Class I	Terminated	24 Apr 2019
Z-1094-2019	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…	18150 devices	Class I	Terminated	24 Apr 2019
Z-1095-2019	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…	300 devices	Class I	Terminated	24 Apr 2019
Z-1096-2019	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…	160775 devices	Class I	Terminated	24 Apr 2019
Z-1097-2019	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…	23800 devices	Class I	Terminated	24 Apr 2019
Z-1098-2019	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…	3500 units	Class I	Terminated	24 Apr 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class I: 6%
Product records in this event: 7Median of the firm: 2
Events of the firm on the register: 75

Other events of the firm

Other FDA enforcement events of ICU Medical, Inc.
Initiated	Product (first record)	Type	Class	Records
20 Aug 2026	CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Code	Device	Class II	1
24 Jun 2026	Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the p	Device	Class II	1
10 Jun 2026	ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump	Device	Class II	2
12 May 2026	Plum administration sets	Device	Class II	8
29 Apr 2026	Plum Solo Precision IV Pump, 40001-0401	Device	Class II	3
24 Mar 2026	Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock	Device	Class II	1
19 Dec 2025	Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000	Device	Class II	1
19 Dec 2025	Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG	Device	Class II	2
15 Dec 2025	Plum Duo Infusion System, List Number 40002-04-01	Device	Class II	1
15 Dec 2025	ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)	Device	Class II	3

ICU Medical, Inc.: all 75 events

Official channels

FDA enforcement report Z-1092-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 82291. https://recallregister.com/fda/i/82291/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.
What quantity of product is in FDA event 82291?: The event has 7 product records. The first record gives this quantity: 27200 devices
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 6% of the 968 device events that started in 2019 are in Class I.