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U.S. Department of Health and Human Services

Class 2 Device Recall Thermoset Room Temperature Closed Loop Injectate Delivery System

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 Class 2 Device Recall Thermoset Room Temperature Closed Loop Injectate Delivery Systemsee related information
Date Initiated by FirmOctober 05, 2018
Create DateDecember 22, 2018
Recall Status1 Terminated 3 on March 25, 2021
Recall NumberZ-0661-2019
Recall Event ID 81210
510(K)NumberK884318 
Product Classification Probe, thermodilution - Product Code KRB
ProductThermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
Code Information 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.   
FEI Number 2025816
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact
844-654-7780
Manufacturer Reason
for Recall		Potential for leakage due to defect in the thermoset check valve component.
FDA Determined
Cause 2		Equipment maintenance
ActionOn October 5, 2018, ICU Medical URGENT MEDCAL DEVICE RECALL letters were sent to ICU Medical's consignees advising them of this matter. Each letter contained a response form and a return label.
Quantity in Commerce27,250 units total
DistributionUnited 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KRB
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