Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
FDA Recall Z-0661-2019 · Posted None
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Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeKRB
Date Initiated2018-10-05
Date Terminated2021-03-25
Product Quantity27,250 units total
Reason for Recall
Potential for leakage due to defect in the thermoset check valve component.
Firm 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.
Root Cause
Equipment maintenance
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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