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Class 2 Device Recall Thermoset Room Temperature Closed Loop Injectate Delivery System |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
October 05, 2018 |
Create Date |
December 22, 2018 |
Recall Status1 |
Terminated 3 on March 25, 2021 |
Recall Number |
Z-0661-2019 |
Recall Event ID |
81210 |
510(K)Number |
K884318
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Product Classification |
Probe, thermodilution - Product Code KRB
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Product |
Thermoset 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. |
Recalling Firm/ Manufacturer |
ICU Medical, Inc. 951 Calle Amanecer San Clemente CA 92673-6212
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For Additional Information Contact |
844-654-7780
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Manufacturer Reason for Recall |
Potential for leakage due to defect in the thermoset check valve component.
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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 |
27,250 units total |
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
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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.
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510(K) Database |
510(K)s with Product Code = KRB and Original Applicant = ABBOTT LABORATORIES
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