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.
What this means for you
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.
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