Recalls / —
—#167794
Product
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
- FDA product code
- KRB — Probe, Thermodilution
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K884318
- Affected lot / code info
- 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.
Why it was recalled
Potential for leakage due to defect in the thermoset check valve component.
Root cause (FDA determination)
Equipment maintenance
Action the firm took
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.
Recalling firm
- Firm
- ICU Medical, Inc.
- Address
- 951 Calle, Amanecer San Clemente, California 92673-6212
Distribution
- 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
Timeline
- Recall initiated
- 2018-10-05
- Terminated
- 2021-03-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #167794. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.