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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 Injectate see related information
Date Initiated by Firm October 05, 2018
Create Date December 22, 2018
Recall Status1 Terminated 3 on March 25, 2021
Recall Number Z-0662-2019
Recall Event ID 81210
510(K)Number K884318  
Product Classification Probe, thermodilution - Product Code KRB
Product Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Code Information 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.
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
Action On 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 Commerce 1,760 units
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
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KRB and Original Applicant = ABBOTT LABORATORIES
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