CLASS II ONGOING Device recall · Reported 19 May 2021 · FDA Enforcement Report

REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave recalled

ICU Medical is recalling REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave, distributed nationwide in the US. The recall was initiated on 16 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF: CH3397 UDI: (01) 1 0840619 07367 8 (17) 251201 (30) 50 (10) 5118610 Lot Number: 5118610

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-1565-2021
FDA event ID: 87703
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Ongoing
Recall initiated: 16 Mar 2021
FDA classified: 13 May 2021
Reported: 19 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

16 Mar 2021	Recall initiated by company
13 May 2021	Classified by FDA	+58 days
19 May 2021	Published in enforcement report	+6 days

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

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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, RI, SD, TN, TX, UT, VA and WA. The countries of Belgium, Canada, France, Italy, South Africa, Spain, United Kingdom.

Nationwide Alaska Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

REF: CH3397 UDI: (01) 1 0840619 07367 8 (17) 251201 (30) 50 (10) 5118610 Lot Number: 5118610

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

25 other products · FDA event 87703

This product is part of a recall event; the main page for the event is REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive recalled.

Reported	Class	Recall	Company	Reason	Where
19 May 2021	CLASS II	REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CH3582 5 IN (13cm) Appx 0.57 ml, EXT SET, Anti-shiphon Valve recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF 011-H2864-HSR 180 cm (71 IN)Appx 11.5ml, PUR Ambr, Spiros recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF 011-H3597 42 cm (16.5 IN) Appx 2.6ml, PUR Transfer SET, Clave recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CL4151 45" (114 cm) Appx 1.7 ml recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF Spinning Spiros Closed Male Luer - Product Usage recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage recalled	ICU Medical	Packaging Defects	Nationwide
19 May 2021	CLASS II	REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage recalled	ICU Medical	Packaging Defects	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 Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide