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U.S. Department of Health and Human Services

Class 2 Device Recall Iced Thermoset ClosedLoop Injectate Delivery System for cold Injectate

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 Class 2 Device Recall Iced Thermoset ClosedLoop Injectate Delivery System for cold Injectatesee related information
Date Initiated by FirmOctober 05, 2018
Create DateDecember 22, 2018
Recall Status1 Terminated 3 on March 25, 2021
Recall NumberZ-0663-2019
Recall Event ID 81210
510(K)NumberK884318 
Product Classification Probe, thermodilution - Product Code KRB
ProductIced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
Code Information 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 
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 Commerce25,640 units
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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