ICU Medical Recalls Thermoset Room Temperature Injectate Delivery Systems
ICU Medical is recalling 27,250 Thermoset Room Temperature Closed Loop Injectate Delivery Systems due to a defect in the thermoset check valve component that may cause leakage.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential for leakage in a medical device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling 27,250 units of the Thermoset Room Temperature Closed Loop Injectate Delivery System (Item number 41412-01). The recall involves specific lots with expiration dates of 01/01/2021, including lot numbers 3591489, 3598125, 3608570, 3610798, 3618041, 3656677, and 3665611.
The recall is being conducted because of a potential for leakage due to a defect in the thermoset check valve component. The affected products were distributed in the United States to the following states and districts: 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, and WY.
Healthcare facilities and consumers should stop using the affected products immediately and contact ICU Medical, Inc. for instructions on how to return the devices or obtain a replacement.
The recalled product
- Product
- Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 27,250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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)
Distribution
Part of a larger recall action
This product is one of 3 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighICU Medical Recalls I.V. Infusion Sets with Potential Leak
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- HighICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls ChemLock I.V. Infusion Administration Sets
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls IV Infusion Sets with Potential ChemoLock Port Leak
FDA (Devices) · 2016-04-06
- SevereICU Medical Recalls Intravascular Administration Sets Due to Seal Defect
FDA (Devices) · 2020-10-28