Device recall: REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the…

Class II FDA enforcement event 87703. Recall start date: 16 Mar 2021. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

ICU Medical, Inc. started this device recall on 16 Mar 2021. The firm address in the FDA record is in San Clemente, CA. FDA put the recall in Class II. FDA event 87703 has 26 product records. The first FDA enforcement report date is 19 May 2021. The record gives the status Ongoing.

FDA enforcement report The 26 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 - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA,…

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

26 product records in the event.

FDA event 87703: product records
Recall number	Product	Class	Status	Report date
Z-1565-2021	REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.	Class II	Ongoing	19 May 2021
Z-1566-2021	REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.	Class II	Ongoing	19 May 2021
Z-1567-2021	REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1568-2021	REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter (which is inserted into a vein)	Class II	Ongoing	19 May 2021
Z-1569-2021	REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1570-2021	REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1571-2021	REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros, Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter…	Class II	Ongoing	19 May 2021
Z-1572-2021	REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock, Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter (which is inserted into a…	Class II	Ongoing	19 May 2021
Z-1573-2021	REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock, Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter (which is inserted into a…	Class II	Ongoing	19 May 2021
Z-1574-2021	REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the…	Class II	Ongoing	19 May 2021
Z-1575-2021	REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which…	Class II	Ongoing	19 May 2021
Z-1576-2021	REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1577-2021	REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1578-2021	REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1579-2021	REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1580-2021	REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a…	Class II	Ongoing	19 May 2021
Z-1581-2021	REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1582-2021	REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1583-2021	REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1584-2021	REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1585-2021	REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1586-2021	REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1587-2021	REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1588-2021	REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021
Z-1589-2021	REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a…	Class II	Ongoing	19 May 2021
Z-1590-2021	REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).	Class II	Ongoing	19 May 2021

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 II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 26Median 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-1565-2021The 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 87703. https://recallregister.com/fda/ii/87703/. 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 - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA,…
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.
How many FDA recalls does ICU Medical, Inc. have?: ICU Medical, Inc. is the recalling firm in 75 enforcement events on this register. This event is 1 of them.