Recall Z-0661-2019 ยท KRB Probe, Thermodilution
ICU Medical, Inc.
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
| Date | Oct 5, 2018 |
| Status | Terminated |
| Reason | Potential for leakage due to defect in the thermoset check valve component. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884318 | THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM Abbott Laboratories, Dec 13, 1988 |