ICU Medical Iced Thermoset Closed-Loop Injectate Delivery System Recall: Potential leakage
ICU Medical recalls 1 unit per cavity of Iced Thermoset Closed-Loop Injectate Delivery System for cold injectate due to potential leakage from a defective thermoset check valve. Affected units have specific lot numbers and expiration dates.
Lower-risk recall
Potential for leakage due to defect in the thermoset check valve component.
Contact the company
What happened, in plain English
ICU Medical is recalling a small number of Iced Thermoset Closed-Loop Injectate Delivery Systems for cold injectate because a defect in the thermoset check valve could cause leakage. This is a minor issue that doesn't pose a serious risk to users. Read more at govinfonow.com/recall/69664-icu-medical-iced-thermoset-closed-loop-injectate-delivery-system-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/69664-icu-medical-iced-thermoset-closed-loop-injectate-delivery-system-recall · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0663-2019
Cite this page
“ICU Medical Iced Thermoset Closed-Loop Injectate Delivery System Recall: Potential leakage.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69664-icu-medical-iced-thermoset-closed-loop-injectate-delivery-system-recall. Based on FDA recall #Z-0663-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0663-2019%22&limit=1).
Why it’s dangerous
The thermoset check valve component has a defect that could lead to leakage of the injectate. This leakage might cause contamination or improper delivery of cold medical fluids, but it does not pose a significant risk of injury or serious harm under normal use.
Who’s affected
Healthcare professionals who use this medical device for cold injectate delivery may be affected. Patients using the device are at low risk due to the small number of units recalled and the nature of the defect.
How to tell if you have this one
Check for the product name 'Iced Thermoset Closed-Loop Injectate Delivery System' with lot numbers 3580033-3585775 and 3598139-3656680. The expiration date is listed as 12/1/2020 or 1/1/2021 depending on the lot.
- Brand
ICU Medical- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO, MS, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0661-2019 | Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090; Item number:41412-01. Lot number (UDI): 3591489 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3591489); 3598125 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3598125); 3608570 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3608570); 3610798 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3610798); 3618041 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3618041); 3656677 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3656677); 3665611 ((01) 0 0840619 04411 4 (17) 210101 (30) 01 (10)3665611). Expiration Date 01/01/2021. | 27,250 units total |
| Z-0662-2019 | Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090; Item number: 41423-03. Lot numbers 3593903, UDI (01) 0 0840619 06347 4 (17) 201201(30) 01 (10)3593903. Lot number 3598129, UDI (01) 0 0840619 06347 4 (17) 201201(30) 01 (10)3598129. Expiration Date 12/01/2020. | 1,760 units |
| Z-0663-2019 | Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645; Item number: 41424-03. Lot number (UDI) Expiration Date: 3580033 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580033) 12/1/2020; 3580037 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580037) 12/1/2020; 3580038 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3580038) 12/1/2020; 3585768 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585768) 12/1/2020; 3585769 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585769) 12/1/2020; 3585770 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585770) 12/1/2020; 3585771 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585771) 12/1/2020; 3585772 ((01) 0 0840619 04414 5 (17) 201201(30) 01 (10)3585772) 12/1/2020; 3585773 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585773) 1/1/2021; 3585774 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585774) 1/1/2021; 3585775 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3585775) 1/1/2021; 3598139 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3598139) 1/1/2021; 3598143 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3598143) 1/1/2021; 3610803 ((01) 0 0840619 04414 5 (17) 210101(30) 01 (10)3610803) 1/1/2021; 3642242 ((01) 0 0840619 04414 5 (17) 210301(30) 01 (10)3642242) 3/1/2021; 3656680 ((01) 0 0840619 04414 5 (17) 210401(30) 01 (10)3656680) 4/1/2021 | 25,640 units |
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the device to determine if it is affected.
Where it went and when
Where it was distributed
Distributed in 30 states and D.C..
FDA distribution: “United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO, MS, MT, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, WY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Colorado, District of Columbia, Florida, Georgia, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0663-2019 (October 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0663-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.