—#167791

Product

Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 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: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.

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 #167791. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.